Considering a Penile Implant? Explore the UNITED Clinical Study
A U.S. Food and Drug Administration-regulated research study evaluating an investigational inflatable penile prosthesis for men with erectile dysfunction. Screening is required and not everyone qualifies. Participation is voluntary.
For eligible beneficiaries, some routine care services may be covered under Medicare rules (Category B IDE). Coverage varies.
Considering a Penile Implant? Explore the UNITED Clinical Study
A U.S. Food and Drug Administration-regulated research study evaluating an investigational inflatable penile prosthesis for men with erectile dysfunction. Screening is required and not everyone qualifies. Participation is voluntary.
For eligible beneficiaries, some routine care services may be covered under Medicare rules (Category B IDE). Coverage varies.
Do You Qualify?
Eligibility is determined by the study team based on specific medical criteria. You may be considered if you:
- Are a male with a diagnosis of erectile dysfunction.
- Are a candidate for penile prosthesis implantation (as determined by the investigator).
- Are willing and able to attend all scheduled follow-up visits for up to 36 months.
- Have no medical conditions that would make surgery unsafe.
Want more details? For a complete list of inclusion and exclusion criteria, visit the official study registration on ClinicalTrials.gov (NCT07273773).
Completing the online pre-screen does not guarantee eligibility. Final confirmation is made by the study doctor.
Participation in the UNITED Study is limited to men who meet specific medical criteria. Find out in less than 60 seconds if you might be a candidate.
Why Participate?
Participation in the UNITED Clinical Study offers eligible individuals the opportunity to take part in a regulated clinical research program evaluating an investigational inflatable penile prosthesis.
- Eligibility & Screening: A brief pre-screen helps determine whether you may meet the study's medical criteria. Completing the pre-screen does not guarantee eligibility or enrollment.
- Access Through Clinical Research: Eligible participants may receive the investigational device as part of a U.S. FDA-regulated clinical study conducted under an Investigational Device Exemption (IDE).
- Specialized Medical Oversight: Participants are monitored by experienced U.S. prosthetic urologists, with scheduled follow-up visits and clinical evaluations throughout the study period.
- Advancing Medical Knowledge: By participating, you contribute valuable data that may help researchers evaluate this investigational device for potential future use in the United States.
Contacting a site does not imply eligibility or enrollment.
Why Participate?
Participation in the UNITED Clinical Study offers eligible individuals the opportunity to take part in a regulated clinical research program evaluating an investigational inflatable penile prosthesis.
- Eligibility & Screening: A brief pre-screen helps determine whether you may meet the study's medical criteria. Completing the pre-screen does not guarantee eligibility or enrollment.
- Access Through Clinical Research: Eligible participants may receive the investigational device as part of a U.S. FDA-regulated clinical study conducted under an Investigational Device Exemption (IDE).
- Specialized Medical Oversight: Participants are monitored by experienced U.S. prosthetic urologists, with scheduled follow-up visits and clinical evaluations throughout the study period.
- Advancing Medical Knowledge: By participating, you contribute valuable data that may help researchers evaluate this investigational device for potential future use in the United States.
Contacting a site does not imply eligibility or enrollment.
UNITED Clinical Study: Frequently Asked Questions
- What is the Infla10® Pulse™ DIPP?
Infla10® Pulse™ DIPP is an investigational, surgically implanted, fluid‑filled device designed to help men with erectile dysfunction achieve penile rigidity for sexual activity.
- Is the device used outside of the U.S.?
Yes. The device is used outside of the U.S., including in the United Kingdom, Australia, South Korea, Germany, and the Middle East/North Africa region.
- What is a clinical trial?
A clinical trial is a research study that evaluates the safety and performance of a medical device or treatment in volunteers under a structured plan.
- What can I expect if I join the study?
If you qualify and choose to participate, you will have an implant procedure and scheduled follow‑up visits (up to 36 months) with questionnaires and routine device checks. Some visits may be done by telehealth when appropriate.
- Will I be compensated?
Participants may be reimbursed for certain study‑related expenses (such as travel or parking), depending on the study site, as outlined in the Informed Consent Form.
- What is the cost of the device? Does Medicare cover the cost?
The study device is investigational and not for sale. The UNITED Study is classified by CMS as a Category B IDE study. For eligible Medicare beneficiaries, routine care services (such as the surgery, hospital stay, and standard doctor visits) may be covered by Medicare, subject to your plan's deductibles and co‑pays. The study team will review your coverage details with you.
- What are the risks of participating in a trial?
Participating may involve surgery‑related and device‑related risks, such as infection, pain, bleeding, scarring, device malfunction, or the need for additional procedures. The study team will walk you through all known and potential risks during the informed consent process.
- Do I qualify to participate?
You may qualify if you are a male age 22 or older with erectile dysfunction, are willing to receive the Infla10® Pulse™ DIPP, and can complete all required follow‑up visits and testing. The study team will confirm eligibility during screening. You can also check your eligibility using the online self‑assessment.
Take the 1-Minute Pre-Screen - Can I change my mind?
Yes. Participation is completely voluntary, and you may leave the study at any time without penalty or loss of standard medical care.
- Will my information be kept private?
Yes. Your personal and medical information will be handled in accordance with privacy and HIPAA regulations.
- What are my rights as a clinical trial participant?
You have the right to ask questions, receive clear information, have your privacy protected, and withdraw from study at any time without penalty or loss of standard medical care.
Disclaimer
This website is a study information and recruitment resource for potential participants and referring physicians related to the clinical study. It is not an offer to sell any device. Investigational Device. Limited by Federal (or United States) law to investigational use. This device is investigational and is being evaluated for safety and effectiveness in clinical studies, including the United Clinical Study for Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis (DIPP). Bench testing data are on file. No clinical performance conclusions can be drawn from bench data. Individual outcomes may vary.