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Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)

NCT05574868 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-12-05

No results posted yet for this study

Summary

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation.

This study will take approximately 6 months to enroll all subjects. (14 days, 6 weeks, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. )

Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

Conditions

Interventions

DEVICE

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis

Treatment: Erectile dysfunction

Sponsors & Collaborators

  • Rigicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Chris Love, Dr. · Urology South at Holmesglen Private Hospital

  • Boon K. Kua, Dr. · Wesley Hospital

  • Hodo Haxhimolla, Dr. · Canberra Laparoscopic, Robotic & Laser Urology Centre

  • Phillip Katelaris, Dr. · Katelaris Urology

  • William Lynch, Dr. · St George Urology

  • Steven Wilson, Dr. · Department of Urology, Institute for Urologic Excellence

  • Paul Perito, MD · Perito Urology - Penile Implant Clinic

  • Gerard Testa, Dr. · Shire Urology

  • Daniel Moon, Dr. · Advanced Urology Melbourne

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-11
Primary Completion
2026-05-21
Completion
2026-05-21
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT05574868 on ClinicalTrials.gov