Actively Recruiting
Evaluation of the Rigicon Infla10 ae Inflatable Penile Prosthesis (IPP) A Prospective, Multicenter, Single-Arm Performance-Goal Study
Led by Rigicon, Inc. · Updated on 2026-02-27
182
Participants Needed
7
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Erectile dysfunction (ED) is a common male sexual problem linked to reduced quality of life and often occurs alongside conditions like diabetes, hypertension, and cardiovascular disease. Researchers are evaluating the long-term safety and effectiveness of the Rigicon Infla10 ae Inflatable Penile Prosthesis (IPP) in men with ED. This study focuses on patients implanted with the Rigicon Infla10 ae Pulse trade; Dynamic Inflatable Penile Prosthesis and follows them for up to three years after implantation. The study involves male participants aged 22 and older who receive the Rigicon Infla10 ae three-piece inflatable penile prosthesis as a treatment for ED. There is a single study group which will be monitored after receiving the device. The device is patient-activated to help achieve and maintain an erection, and the study assesses its safety and function over time. Participants will have regular follow-up visits over three years to complete tests and assessments. Researchers will monitor for any device- or procedure-related adverse events during the first 12 months and evaluate penile rigidity at 12 months. Other measures include tracking revision surgeries, erectile function scores, self-esteem scales, and adverse events throughout the study period. Participants must agree to follow all study protocols and attend scheduled visits.
CONDITIONS
Brief Title
Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 22 years of age or older
- Diagnosed with erectile dysfunction (impotence)
- Agree to receive the Infla10�ae three-piece inflatable penile prosthesis as ED treatment
- Willing to complete all required follow-up visits and tests
You will not qualify if you...
- Contraindicated for general anesthesia
- Known allergy or sensitivity to device materials
- Previous penile prosthesis or enlargement surgeries
- Diagnosed penile sensory neuropathy
- Receiving immunosuppressive drugs or history of kidney transplant
- Receiving chemotherapy at enrollment
- Diagnosed with fibrotic diseases like priapism, Peyronie's disease, or Chordee
- Compromised immune system conditions such as lupus or scleroderma
- Uncontrolled diabetes with HbA1c �greater or equal to 9.0% within 90 days before surgery
- Bleeding disorders that preclude safe procedure
- Active urogenital or skin infection near surgery
- Significant unstable comorbidities affecting study safety
- Lacking manual dexterity or mental ability to operate device
- Expected life expectancy less than two years
- Unwilling or unable to sign informed consent
- Unwilling or unable to comply with follow-up requirements
- Psychogenic erectile dysfunction
- Currently participating in another investigational drug or device study
- Cognitive disorders impairing communication or questionnaire completion
- Incarcerated individuals
- Currently using or never tried standard non-surgical ED therapies including oral or topical treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus initial recovery period
Participants receive the Rigicon Infla10® Inflatable Penile Prosthesis implantation surgery and immediate post-surgery care.
1 visit for implantation surgery
Duration - Up to 36 months post-implantation
Participants attend follow-up visits to monitor safety and effectiveness of the penile prosthesis and to complete assessments.
Visits at Months 3, 6, 12, 18, 24, and 36 post-implantation
Trial Site Locations
Total: 7 locations
1
Perito Urology
Coral Gables, Florida, United States, 33146
Actively Recruiting
2
Atlanta Cosmetic Urology
Atlanta, Georgia, United States, 30305
Actively Recruiting
3
UroPartners
Chicago, Illinois, United States, 60612
Not Yet Recruiting
4
Kramer Urology
Hyannis, Massachusetts, United States, 02601
Not Yet Recruiting
5
Washington Heights Urology
New York, New York, United States, 10032
Actively Recruiting
6
Urology Partners of North Texas
Arlington, Texas, United States, 76017
Not Yet Recruiting
7
Vitality Urology Institute
Houston, Texas, United States, 77024
Not Yet Recruiting
Research Team
Z
Zeynep Tin Konukcu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here