Actively Recruiting
Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
Led by Rigicon, Inc. · Updated on 2026-02-27
182
Participants Needed
7
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the long-term safety and effectiveness of the Rigicon Infla10® Inflatable Penile Prosthesis in patients with erectile dysfunction. The study follows patients implanted with the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for up to 3 years after implantation.
CONDITIONS
Official 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
- Agree to receive Infla10� three-piece IPP as treatment for erectile dysfunction
- Willing to complete all required follow-up visits and tests
You will not qualify if you...
- Contraindication to 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 transplantation
- 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 6ge; 9.0% measured within 90 days before surgery
- Bleeding disorders or coagulopathy that preclude safe surgery
- Active urogenital or skin infections or systemic infection at assessment
- Significant comorbidities or unstable conditions that may affect safety or study results
- Lack of manual dexterity or mental ability to operate the device
- 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 other investigational drug or device studies
- Cognitive disorders affecting communication or study participation
- Incarcerated individuals
- Currently using or have not tried and failed standard non-surgical ED therapies including oral or topical treatments
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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