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New treatment option for Erectile Dysfunction (ED)
Official title Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
ClinicalTrials.gov ID: NCT07273773
What this study is testing
- What it's testing
- 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.
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, men only
You may be able to join 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 likely can't join 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.
See the full eligibility criteria
- 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.
- 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...
- Lacking manual dexterity or mental abilities necessary to operate the device.
- Expected life expectancy \< two years.
- Unwilling or unable to sign the Informed Consent.
- Unwilling or unable to comply with the follow-up study requirements.
- Psychogenic erectile dysfunction
- Currently participating in an investigational drug or another investigational device exemption (IDE) study.
- The cognitively challenged people and people 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...
- Incarcerated people
- people who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.
The study team makes the final eligibility decision.
Where it's taking place
- Coral Gables, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Hyannis, Massachusetts, United States
- New York, New York, United States
- Arlington, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coral Gables, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Hyannis, Massachusetts, United States; New York, New York, United States; Arlington, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.