Rigicon clinical trial in USA?

[jackhammerdreamz]

Ah I see you are in the thread Daridima made. Awesome!

I am happy to hear about a 3rd contender stepping into the ring because the more competition the more likely innovation.

When my Coloplast Titan failed in September, my surgeon did note that Coloplast is looking to add a layer of durability to the prosthetic.

I don't remember the exact details but it sounds like a portion of the implant is coated with this layer, but the tubes and/or pump are not.
He said it would have to be trialed and approved by the FDA first of course to make it something insurance would cover.

I was of course not going to wait around for years in anticipation for insurance approval and I wasn't going to spend thousands out of pocket
(my initial implant surgery costs were $75k and I paid $1300 thanks to insurance coverage)

The pros and cons of the implants available via trial or on the market are not dealbreakers for me... I understand everyone is different.

As men, we fixate on length...
The AMS LGX can stretch to add a little length, but I guarantee you a woman having sex with an LGX implant before and after it stretched would not know the difference much less care.
The Coloplast is known to give a harder and wider erection, I know that I don't have experience with the LGX, but women have given comments to me where they felt "full" when I was inside them. Full in a good way of course lol....
I can tell you that ZERO percent wanted to be bashed in the cervix by a long dong
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The durability of the 4th layer will take years of study to validate if and how much it makes a difference. None of these IPP are meant to last forever.
But maybe someday we'll have some nanobot boner machines we can just install and control our boners with bluetooth
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I don't want you to think I'm being dismissive of your research, I just want you to understand that there's no really wrong choice of implant.
All 3 IPP will 100% perform better than a penis afflicted with ED, all 3 will restore confidence and improve some quality of life at least in the bedroom
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Keep us posted on if/when you decide to go under the knife

[Discovernew]

Ok, I can accept your logic but it has a huge hole in it. Where are you going to find men that have had both implants? Have you calculated how long that might take? Please remember that only a very very small percentage of implanted men belong to FT.

I want to point out that if the Rigicon is superior per you claims? You can fly somewhere to get one tomorrow. I forget the technical name for it. But your quest is over riding common sense.

In Air Force speak. Its called target fixation. You concetrate so strongly on a target that you fly into the ground. You end your life concetrating on that target.

I'm working unnatrually hard to convice you to not fly into the ground.

I didn't say men who had both implants. I said doctors who installed both implants (coloplast and rigicon), that's why i want to know the name of the doctors and speak with them, which is the original question of this post.

Of doctors, I only know about Antonini, who offers both coloplast and rigicon, karaman and doctor Rosello in Spain. They are the ones I know.

Thanks for the info! I know Karaman, but i think he does not work with Coloplast. So it would not be a fair comparison. I never spoke with Antonini but people here in the forum say bad things about him. I never heard about Rosello, are you sure he works with both brands, and do you have a good references about him? thanks for the info!

[Gt1956]

I didn't say men who had both implants. I said doctors who installed both implants (coloplast and rigicon), that's why i want to know the name of the doctors and speak with them, which is the original question of this post.

Of doctors, I only know about Antonini, who offers both coloplast and rigicon, karaman and doctor Rosello in Spain. They are the ones I know.

Thanks for the info! I know Karaman, but i think he does not work with Coloplast. So it would not be a fair comparison. I never spoke with Antonini but people here in the forum say bad things about him. I never heard about Rosello, are you sure he works with both brands, and do you have a good references about him? thanks for the info!

Some drs will offer more than one brand. Some switch between brands over the years. Please remember that if you go with a Coloplast IPP that they only make one model. My dr only uses AMS (Boston Scientific) implants. AMS make two models, LGX & CX. Plus they make a reduced diameter model for less girthy patients. So you can go to a dr that only has one choice or a dr that has three choices. The number of brands your dr uses is not as important as how many models he has to chose from.

[Lost Sheep]

Of doctors, I only know about Antonini, who offers both coloplast and rigicon, karaman and doctor Rosello in Spain. They are the ones I know.

Thanks for the info! I know Karaman, but i think he does not work with Coloplast. So it would not be a fair comparison. I never spoke with Antonini but people here in the forum say bad things about him. I never heard about Rosello, are you sure he works with both brands, and do you have a good references about him? thanks for the info!

Some drs will offer more than one brand. Some switch between brands over the years. Please remember that if you go with a Coloplast IPP that they only make one model. My dr only uses AMS (Boston Scientific) implants. AMS make two models, LGX & CX. Plus they make a reduced diameter model for less girthy patients. So you can go to a dr that only has one choice or a dr that has three choices. The number of brands your dr uses is not as important as how many models he has to chose from.

Coloplast also has a reduced-diameter IPP.

[Flounder]

Discovernew, lets do the math on your hopes for a new implant company in the USA. Assign whatever time to each step you'd like. But rest assured that its likely your time estimates will be woefully over optimistic.

Get a statically number implanted.
Wait several years to see the results.
Compile & organize the results.
Distribute the results to the study drs for feedback.
Submit said study to the FDA.
IF the FDA doesn't ask for more data. Maybe approve them after a year or three.
Now Rigicon will ramp up production to meet expected demand.

As people say. The goverment moves at the speed of cold tar in the winter time. Meanwhile you're sitting at home watching all these age appropriate to you pretty girls get married, fat or get a tribe of kids by a guy that can't pay child support. Maybe even all three things.

Then, by some bizarre stroke of luck. You might hear of a new & improved implant that you want to wait for.

Hey, just some old guy on the internets advice. Get the best for you implant asap once you need it. You can't go back in time to get those missed sexual encounters. They are gone forever.

So curiosity is getting the best of me. How about educating the forum on some detailed reasons you want to wait for a new implant. I've given some reasonable reasons to not wait. Its your turn now.

The reason is the following: I am currently deciding which brand to use for my own implant. Some doctors abroad (e.g Karaman, Koeenrad) say the infla 10 AX from rigicon is a great product with several alleged benefits. However, most doctors in USA have no first hand experience with it. If such trial exists, means implant is indeed being installed by some doctors on a trial basis. I want to reach out to them so they can tell me if Rigicon is any good or i should stick to Coloplast (but i won't take advise from someone who hasn't used both of them). Does that make sense?

At that point, i don't care when it is approved in the USA, i can fly anywhere in the world to get the implant done.

Discover new, I understand your intention but I believe your desired outcome is flawed. I worked for a global Fortune 100 company and spent a good part of my career in quality management and new product development. While the products I worked with weren’t medical, the ISO product development model is quite similar across all products and services. I don’t know the specifics or even if a Rigicon trial exists in the US. However I am well versed in how the product development and trials process work in regulate industries.

When a product is ready to go to trials, trusted dealers (surgeons) and end users (patients) are selected. The selection criteria can be complex in an effort to qualify unbiased participants. The participants may be compensated for their time and expenses. However compensation or gifts that could be construed as a bribe or payoff, for desired trial outcomes, is not permitted. The governing bodies will scrutinize this.

Now here is why I believe your intentions are unattainable. In any trial of significance, all participants must be willing to sign a non-disclosure agreement. Generally speaking, participants can be held liable for discussing with outsiders anything pertaining to the trial while it’s in process. I don’t know if Perito is participating in the trial or not. Let’s assume he is. He would be a fool (which he’s not) to take a call from some unknown Joe Blow asking for information about the trial. Same can be said for anyone else participating in the trial.

The best advice I can give is abandon any hope of getting information from the US surgeons in the foreseeable future. I think your research is limited to doctors or patients abroad who are now free to express their opinions of rigicon infla 10 AX vs Coloplast. If you like what you hear from abroad, hop on the big old jet airliner and get the Rigicon implant where it’s now available. If you do so, please report back your satisfaction. A lot of readers here are curious.

[Gt1956]

Discovernew, lets do the math on your hopes for a new implant company in the USA. Assign whatever time to each step you'd like. But rest assured that its likely your time estimates will be woefully over optimistic.
Get a statically number implanted.
Wait several years to see the results.
Compile & organize the results.
Distribute the results to the study drs for feedback.
Submit said study to the FDA.
IF the FDA doesn't ask for more data. Maybe approve them after a year or three.
Now Rigicon will ramp up production to meet expected demand.
As people say. The goverment moves at the speed of cold tar in the winter time. Meanwhile you're sitting at home watching all these age appropriate to you pretty girls get married, fat or get a tribe of kids by a guy that can't pay child support. Maybe even all three things.
Then, by some bizarre stroke of luck. You might hear of a new & improved implant that you want to wait for.
Hey, just some old guy on the internets advice. Get the best for you implant asap once you need it. You can't go back in time to get those missed sexual encounters. They are gone forever.
So curiosity is getting the best of me. How about educating the forum on some detailed reasons you want to wait for a new implant. I've given some reasonable reasons to not wait. Its your turn now.

The reason is the following: I am currently deciding which brand to use for my own implant. Some doctors abroad (e.g Karaman, Koeenrad) say the infla 10 AX from rigicon is a great product with several alleged benefits. However, most doctors in USA have no first hand experience with it. If such trial exists, means implant is indeed being installed by some doctors on a trial basis. I want to reach out to them so they can tell me if Rigicon is any good or i should stick to Coloplast (but i won't take advise from someone who hasn't used both of them). Does that make sense?
At that point, i don't care when it is approved in the USA, i can fly anywhere in the world to get the implant done.

Discover new, I understand your intention but I believe your desired outcome is flawed. I worked for a global Fortune 100 company and spent a good part of my career in quality management and new product development. While the products I worked with weren’t medical, the ISO product development model is quite similar across all products and services. I don’t know the specifics or even if a Rigicon trial exists in the US. However I am well versed in how the product development and trials process work in regulate industries.
When a product is ready to go to trials, trusted dealers (surgeons) and end users (patients) are selected. The selection criteria can be complex in an effort to qualify unbiased participants. The participants may be compensated for their time and expenses. However compensation or gifts that could be construed as a bribe or payoff, for desired trial outcomes, is not permitted. The governing bodies will scrutinize this.
Now here is why I believe your intentions are unattainable. In any trial of significance, all participants must be willing to sign a non-disclosure agreement. Generally speaking, participants can be held liable for discussing with outsiders anything pertaining to the trial while it’s in process. I don’t know if Perito is participating in the trial or not. Let’s assume he is. He would be a fool (which he’s not) to take a call from some unknown Joe Blow asking for information about the trial. Same can be said for anyone else participating in the trial.
The best advice I can give is abandon any hope of getting information from the US surgeons in the foreseeable future. I think your research is limited to doctors or patients abroad who are now free to express their opinions of rigicon infla 10 AX vs Coloplast. If you like what you hear from abroad, hop on the big old jet airliner and get the Rigicon implant where it’s now available. If you do so, please report back your satisfaction. A lot of readers here are curious.

Flounder, your opinion is right on. Under trials does not mean blab your info to anyone with a phone.

Also, to get into the trial I'm sure that you must meet their selection criteria. They do not want their data corrupted by too many participants in selected groups.

FWIW, I had to sign a NDA inorder to make some custom washers. Yes, I said washers.

[jl33ur]

I didn't say men who had both implants. I said doctors who installed both implants (coloplast and rigicon), that's why i want to know the name of the doctors and speak with them, which is the original question of this post.

Of doctors, I only know about Antonini, who offers both coloplast and rigicon, karaman and doctor Rosello in Spain. They are the ones I know.

Thanks for the info! I know Karaman, but i think he does not work with Coloplast. So it would not be a fair comparison. I never spoke with Antonini but people here in the forum say bad things about him. I never heard about Rosello, are you sure he works with both brands, and do you have a good references about him? thanks for the info!

There are several young people here who have had surgery with Antonini and they are quite happy, and they haven't needed any revision for several years... I for one asked him and he works with all the brands, but the price is not within my reach ( 30k)... and rosello is high volume here in Spain because it operates both privately and publicly and offers all brands, in fact there is a newspaper article that talks about rigicon... the price is also out of my pocket 20k .

[Discovernew]

Of doctors, I only know about Antonini, who offers both coloplast and rigicon, karaman and doctor Rosello in Spain. They are the ones I know.

Thanks for the info! I know Karaman, but i think he does not work with Coloplast. So it would not be a fair comparison. I never spoke with Antonini but people here in the forum say bad things about him. I never heard about Rosello, are you sure he works with both brands, and do you have a good references about him? thanks for the info!

There are several young people here who have had surgery with Antonini and they are quite happy, and they haven't needed any revision for several years... I for one asked him and he works with all the brands, but the price is not within my reach ( 30k)... and rosello is high volume here in Spain because it operates both privately and publicly and offers all brands, in fact there is a newspaper article that talks about rigicon... the price is also out of my pocket 20k .

Amazing info, thank you very much! I will make sure to contact Rosello at least for a consultation.

[Discovernew]

Discovernew, lets do the math on your hopes for a new implant company in the USA. Assign whatever time to each step you'd like. But rest assured that its likely your time estimates will be woefully over optimistic.

Get a statically number implanted.
Wait several years to see the results.
Compile & organize the results.
Distribute the results to the study drs for feedback.
Submit said study to the FDA.
IF the FDA doesn't ask for more data. Maybe approve them after a year or three.
Now Rigicon will ramp up production to meet expected demand.

As people say. The goverment moves at the speed of cold tar in the winter time. Meanwhile you're sitting at home watching all these age appropriate to you pretty girls get married, fat or get a tribe of kids by a guy that can't pay child support. Maybe even all three things.

Then, by some bizarre stroke of luck. You might hear of a new & improved implant that you want to wait for.

Hey, just some old guy on the internets advice. Get the best for you implant asap once you need it. You can't go back in time to get those missed sexual encounters. They are gone forever.

So curiosity is getting the best of me. How about educating the forum on some detailed reasons you want to wait for a new implant. I've given some reasonable reasons to not wait. Its your turn now.

The reason is the following: I am currently deciding which brand to use for my own implant. Some doctors abroad (e.g Karaman, Koeenrad) say the infla 10 AX from rigicon is a great product with several alleged benefits. However, most doctors in USA have no first hand experience with it. If such trial exists, means implant is indeed being installed by some doctors on a trial basis. I want to reach out to them so they can tell me if Rigicon is any good or i should stick to Coloplast (but i won't take advise from someone who hasn't used both of them). Does that make sense?

At that point, i don't care when it is approved in the USA, i can fly anywhere in the world to get the implant done.

Discover new, I understand your intention but I believe your desired outcome is flawed. I worked for a global Fortune 100 company and spent a good part of my career in quality management and new product development. While the products I worked with weren’t medical, the ISO product development model is quite similar across all products and services. I don’t know the specifics or even if a Rigicon trial exists in the US. However I am well versed in how the product development and trials process work in regulate industries.

When a product is ready to go to trials, trusted dealers (surgeons) and end users (patients) are selected. The selection criteria can be complex in an effort to qualify unbiased participants. The participants may be compensated for their time and expenses. However compensation or gifts that could be construed as a bribe or payoff, for desired trial outcomes, is not permitted. The governing bodies will scrutinize this.

Now here is why I believe your intentions are unattainable. In any trial of significance, all participants must be willing to sign a non-disclosure agreement. Generally speaking, participants can be held liable for discussing with outsiders anything pertaining to the trial while it’s in process. I don’t know if Perito is participating in the trial or not. Let’s assume he is. He would be a fool (which he’s not) to take a call from some unknown Joe Blow asking for information about the trial. Same can be said for anyone else participating in the trial.

The best advice I can give is abandon any hope of getting information from the US surgeons in the foreseeable future. I think your research is limited to doctors or patients abroad who are now free to express their opinions of rigicon infla 10 AX vs Coloplast. If you like what you hear from abroad, hop on the big old jet airliner and get the Rigicon implant where it’s now available. If you do so, please report back your satisfaction. A lot of readers here are curious.

Thank you! Actually that makes sense. It didn't cross my mind that NDAs might be in place. So yes, my best bet is asking abroad to doctors who have already done implants with Rigicon + Coloplast (needs to both to be a fair comparison, as any doctor who works with only 1 brand is biased).

Will try with the Spanish doctor another user mentioned here.

[Discovernew]

Of doctors, I only know about Antonini, who offers both coloplast and rigicon, karaman and doctor Rosello in Spain. They are the ones I know.

Thanks for the info! I know Karaman, but i think he does not work with Coloplast. So it would not be a fair comparison. I never spoke with Antonini but people here in the forum say bad things about him. I never heard about Rosello, are you sure he works with both brands, and do you have a good references about him? thanks for the info!

There are several young people here who have had surgery with Antonini and they are quite happy, and they haven't needed any revision for several years... I for one asked him and he works with all the brands, but the price is not within my reach ( 30k)... and rosello is high volume here in Spain because it operates both privately and publicly and offers all brands, in fact there is a newspaper article that talks about rigicon... the price is also out of my pocket 20k .

Hi, can you let me know if this is the Dr Rosello that you mention? I saw only one video of him on youtube but it is a very old video and the doctor himself looks a bit old in the video. But there are also other Drs with the name Rosello.

And what is the best way to contact him? Do you have any direct contact from him?

https://www.youtube.com/watch?v=7SrDdAAJeaA