Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
NCT ID: NCT07273773
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
182 participants
INTERVENTIONAL
2026-01-31
2029-07-31
Brief Summary
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Detailed Description
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Management of ED involves lifestyle modification, medical, surgical interventions, and possibly, in the future, tissue- engineering or cellular or gene therapy. Oral phosphodiesterase type 5 inhibitor (PDE5i), which works with sexual stimulation, is an effective medical therapy for ED with an excellent safety profile. Intracavernosal injection or topical application of vasoactive drugs have also been studied. The first inflatable penile prosthesis was introduced in 1973, and current models of inflatable penile prostheses include the AMS 700 series, Coloplast Titan device and Zephyr ZSI device. A patient-activated inflatable penile prosthesis (IPP) provides patients with a means to achieve dependable spontaneity for intercourse.
Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Rigicon Infla10® Inflatable Penile Prosthesis (IPP)
Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis
• Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction
Interventions
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Rigicon Infla10® Inflatable Penile Prosthesis (IPP)
Medical Device: Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis
• Other Names: Inflatable Penile Prosthesis (IPP) Treatment: Erectile dysfunction
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with erectile dysfunction (impotence).
3. Agree to receive Infla10® three-piece IPP as an ED treatment.
4. Willing to complete all protocol required for follow-up visits and tests.
Exclusion Criteria
2. Known allergy or sensitivity to product materials as indicated in the device labeling.
3. Previous penile prosthesis or prior enlargement surgeries
4. Diagnosed penile sensory neuropathy.
5. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation.
6. Patients who are receiving chemotherapy at the time of enrolment.
7. Diagnosed with fibrotic disease, such as priapism or Peyronie's disease or Chordee.
8. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma.
9. Uncontrolled diabetes (HbA1c ≥ 9.0% \[≈75 mmol/mol\], measured within 90 days prior to surgery.
10. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
11. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
12. 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.
13. Lacking manual dexterity or mental abilities necessary to operate the device.
14. Expected life expectancy \< two years.
15. Unwilling or unable to sign the Informed Consent.
16. Unwilling or unable to comply with the follow-up study requirements.
17. Psychogenic erectile dysfunction
18. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
19. The cognitively challenged subjects and subjects with 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.
20. Incarcerated subjects
21. Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.
22 Years
MALE
No
Sponsors
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Rigicon, Inc.
INDUSTRY
Responsible Party
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Locations
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Perito Urology
Coral Gables, Florida, United States
Atlanta Cosmetic Urology
Atlanta, Georgia, United States
Dr. Levine Men's Health
Chicago, Illinois, United States
Kramer Urology
Hyannis, Massachusetts, United States
Premier Medical Group
New Windsor, New York, United States
Washington Heights Urology
New York, New York, United States
Sun Health Clinic
Arlington, Texas, United States
Vitality Urology Institute
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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RC2025_UNITED
Identifier Type: -
Identifier Source: org_study_id