Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Rigicon, Inc.
Study ID
NCT07273773
Status
Recruiting
Apply to this trial

Conditions

  • Erectile Dysfunction (ED)

Eligibility Criteria

Sex
MALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rigicon Infla10® Inflatable Penile Prosthesis (IPP) — DEVICE
    Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis • Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction

Study Details

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.

Key Dates

Start date
Jan 26, 2026
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
182 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis
    Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.

Primary Outcome Measure

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 v5.0 and IPP-specific mapping. [ Time Frame: 12 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Perito UrologyCoral GablesFlorida33146-
Atlanta Cosmetic UrologyAtlantaGeorgia30305-
UroPartnersChicagoIllinois60612-
Kramer UrologyHyannisMassachusetts02601-
Washington Heights UrologyNew YorkNew York10032-
Urology Partners of North TexasArlingtonTexas76017-
Vitality Urology InstituteHoustonTexas77024-

Find similar trials in Coral Gables, FL

By research site
Perito Urology· Coral Gables, FLAtlanta Cosmetic Urology· Atlanta, GAUroPartners· Chicago, ILKramer Urology· Hyannis, MAWashington Heights Urology· New York, NYUrology Partners of North Texas· Arlington, TX

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