Rigicon Infla10® Inflatable Penile Prosthesis for Erectile Dysfunction
This study is looking at the long-term safety and how well the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) works for men with erectile dysfunction (ED). ED is when you have trouble getting or keeping an erection. The study will follow about 182 men who receive the Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis as a treatment for their ED. To join, you must be a male at least 22 years old, have ED, and agree to get the Infla10® IPP. The study will measure safety by checking for any device or procedure-related problems for 12 months. Effectiveness will be measured by how well the device helps with penile rigidity after 12 months.
- Study design
- This is an interventional study planning to enroll 182 male participants. It is evaluating a medical device for erectile dysfunction.
- What's involved
- You would receive the Infla10® three-piece IPP as an ED treatment and agree to complete all required follow-up visits and tests.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 3 years after the implantation of the device. Safety and effectiveness will be measured at 12 months.
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Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
At a glance
Conditions
Where it's being run
4 sites across 3 statesWho to contact
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What this trial measures
- The primary safety outcome is the proportion of participants free from any device- or procedure-related adverse event of CTCAE Grade ≥2 through 12 months post-procedure, graded per CTCAE v6.0 and IPP-specific mapping.12 months
Success will be concluded if the two-sided 95 percent confidence interval (equivalently, one-sided 97.5 percent) for the 12-month proportion has its lower bound strictly greater than 0.90 as specified in the statistical plan.
- The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 12 months.12 months
The objective axial rigidity test will use a calibrated axial-rigidity device to measure vertical displacement of the fully inflated penis under a standardized 650-gram load. ≤15 mm displacement will be counted as a "pass". Success will be concluded if the two-sided 95 percent confidence interval for the 12-month success proportion has its lower bound strictly greater than the pre-specified performance goal in the statistical plan.