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Recruiting
NCT05574868
Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED)
Conditions: Erectile Dysfunction
Sex: Male
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 182
Sponsor: Rigicon, Inc.
Location: Wesley Hospital Auchenflower
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.
Eligibility Criteria
Inclusion Criteria:
1. Male ≥22 years of age.
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 follow-up visits and tests.
Exclusion Criteria:
1. Contraindication to general anesthesia.
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. Diagnosed with fibrotic disease, such as priapism, Peyronie's disease or Chordee.
6. Compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
7. Patients who are receiving immunosuppressive drugs or have a history of kidney transplantation
8. Uncontrolled diabetes (Fasting Blood Sugar FBS) \>300 or HbA1c ≥9.0 on morning of surgery)
9. Bleeding disorder or coagulopathy that may in the judgment of the investigator preclude safe procedure.
10. Active urogenital infection or active skin infection in region of surgery or systemic infection at the time of assessment.
11. 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.
12. 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.
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. Currently participating in an investigational drug or another investigational device exemption (IDE) study.
18. Incarcerated subjects
19. Psychogenic erectile dysfunction
Source: ClinicalTrials.gov (NCT05574868). StuddyBuddy aggregates publicly available trial information.