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

NCT07273773 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-02-27

No results posted yet for this study

Summary

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

  • Erectile Dysfunction (ED)

Interventions

DEVICE

Rigicon Infla10® Inflatable Penile Prosthesis (IPP)

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

Sponsors & Collaborators

  • Rigicon, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-26
Primary Completion
2027-07-31
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273773 on ClinicalTrials.gov