NCT07273773 · Rigicon, Inc.
Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction
(UNITED)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
Exclusion criteria
- 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 results of the study or in the judgment of the physician investigator preclude safe procedure.
- 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 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.
- Incarcerated subjects
- Subjects who are currently using, or who have not previously attempted and failed, standard non-surgical ED therapies including oral or topical treatments.
Where
- Coral Gables, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Hyannis, Massachusetts
- New York, New York
- Arlington, Texas
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations