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

NCT05574868 | Recruiting DMC FDA Device

• 1 other identifier: RGN-ED-IPP-202201
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 7

Brief 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

Erectile Dysfunction

Keywords

Infla10; Rigicon; Dynamic; Erectile Dysfunction; Inflatable Penile Prosthesis; Penile Prosthesis

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.

  Description: 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.

  Description: 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 (3)

• Durability

  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.

Other Outcomes (1)

• Adverse Events

  36 months

Study Arms (1)

Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group

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 Infla 10® Three-Piece Inflatable Penile Prosthesis

Interventions

Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis DEVICE

Treatment: Erectile dysfunction

Also known as: IPP

Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group

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 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.
• Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
• Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
• Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
• Uncontrolled diabetes (Fasting Blood Sugar FBS) \>300 or HbA1c ≥9.0 on morning of 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.
• Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study questionnaires.
• 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)

Wesley Hospital

Auchenflower, Australia

RECRUITING

Canberra Laparoscopic, Robotic & Laser Urology Centre

Garran, Australia

RECRUITING

Katelaris Urology

Hornsby, Australia

RECRUITING

St George Urology

Hurstville, Australia

RECRUITING

Advanced Urology Melbourne

Malvern, Australia

RECRUITING

Shire Urology

Miranda, Australia

RECRUITING

Urology South at Holmesglen Private Hospital

Moorabbin, Australia

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

Study Officials

• Chris Love, Dr.

  Urology South at Holmesglen Private Hospital

  PRINCIPAL INVESTIGATOR

• Boon K. Kua, Dr.

  Wesley Hospital

  STUDY DIRECTOR

• Hodo Haxhimolla, Dr.

  Canberra Laparoscopic, Robotic & Laser Urology Centre

  STUDY DIRECTOR

• Phillip Katelaris, Dr.

  Katelaris Urology

  STUDY DIRECTOR

• William Lynch, Dr.

  St George Urology

  STUDY DIRECTOR

• Steven Wilson, Dr.

  Department of Urology, Institute for Urologic Excellence

  STUDY DIRECTOR

• Paul Perito, MD

  Perito Urology - Penile Implant Clinic

  STUDY DIRECTOR

• Gerard Testa, Dr.

  Shire Urology

  STUDY DIRECTOR

• Daniel Moon, Dr.

  Advanced Urology Melbourne

  STUDY DIRECTOR

Central Study Contacts

Zeynep Tin Konukcu

CONTACT

888-202-9790; clinical@rigicon.com

Feyzanur CALDIRAN, PhD

CONTACT

888-202-9790; fcaldiran@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: October 6, 2022
• First Posted: October 12, 2022
• Study Start: July 11, 2022
• Primary Completion: May 21, 2026
• Study Completion: May 21, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)