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

NCT07273773 | Recruiting DMC FDA Device

• 1 other identifier: RC2025_UNITED
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 7

Brief 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)

Keywords

Rigicon; Infla10; inflatable penile prosthesis; penile prosthesis; Dynamic; erectile dysfunction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

• The primary effectiveness endpoint is a binary "pass" or "fail" objective axial rigidity test, assessed at 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.

  12 months

Secondary Outcomes (4)

• Percentage of patients free from revision or explant surgeries at 12 months.

  12 months

• International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score

  Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.

• Rosenberg Self-Esteem Scale (RSES) Total Score

  Baseline (pre-implantation) and Months 3, 6, 12, 18, 24, and 36 post-implantation.

• Adverse Events

  36 months

Study Arms (1)

Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis

EXPERIMENTAL

Male subjects 22 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.

Device: Rigicon Infla10® Inflatable Penile Prosthesis (IPP)

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

Patients implanted with Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis

Eligibility Criteria

• Age: 22 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male ≥22 years of age.
• Diagnosed with erectile dysfunction (impotence).
• Agree to receive Infla10® three-piece IPP as an ED treatment.
• Willing to complete all protocol required for follow-up visits and tests.

You may not qualify if:

• Contraindication to general anesthesia.
• Known allergy or sensitivity to product materials as indicated in the device labeling.
• Previous penile prosthesis or prior enlargement surgeries
• Diagnosed penile sensory neuropathy.
• Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
• Patients who are receiving chemotherapy at the time of enrolment.
• Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
• Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.
• Uncontrolled diabetes (HbA1c ≥ 9.0% \[≈75 mmol/mol\], measured within 90 days prior to surgery.
• Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
• Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
• Clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or in the judgment of the physician investigator preclude safe procedure.
• Lacking manual dexterity or mental abilities necessary to operate the device.
• Expected life expectancy \< two years.
• Unwilling or unable to sign the Informed Consent.

Sponsors & Collaborators

• Rigicon, Inc.: lead

Study Sites (7)

Perito Urology

Coral Gables, Florida, 33146, United States

RECRUITING

Atlanta Cosmetic Urology

Atlanta, Georgia, 30305, United States

RECRUITING

UroPartners

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Kramer Urology

Hyannis, Massachusetts, 02601, United States

NOT YET RECRUITING

Washington Heights Urology

New York, New York, 10032, United States

RECRUITING

Urology Partners of North Texas

Arlington, Texas, 76017, United States

NOT YET RECRUITING

Vitality Urology Institute

Houston, Texas, 77024, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Zeynep Tin Konukcu

CONTACT

888-202-9790; clinical@rigicon.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 10, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

US (7)