The UNITED Investigational Penile Prosthesis Study
The UNITED Clinical Study is a U.S. FDA-regulated clinical study being conducted under an Investigational Device Exemption (IDE) evaluating an investigational penile prosthesis. The study is collecting information on the safety and effectiveness of the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis in men with erectile dysfunction.
The UNITED Investigational Penile Prosthesis Study
The UNITED Clinical Study is a U.S. FDA-regulated clinical study being conducted under an Investigational Device Exemption (IDE) evaluating an investigational penile prosthesis. The study is collecting information on the safety and effectiveness of the Rigicon Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis in men with erectile dysfunction.
ED Self-Check
This self-check is informational and does not diagnose erectile dysfunction or determine eligibility. If you choose to provide contact information, a study team member may contact you to share general study information. Please do not submit medical records or sensitive personal health information through this website. Eligibility is determined by the participating study site during screening.
Start the Self-CheckInfla10® Pulse™ Series
The device is an investigational product being evaluated in the United Clinical Study for Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis (DIPP). It is intended for men who may be candidates for penile prosthesis implantation. This three-piece, fluid-filled system (two cylinders, pump, reservoir) is designed to allow the user to control penile rigidity. Specifications and bench testing are conducted under laboratory conditions and are not predictive of individual clinical outcomes.
Important: This device is investigational and is being evaluated for safety and effectiveness in clinical studies. Bench testing data are on file. No clinical performance conclusions can be drawn from bench data. Individual outcomes may vary based on anatomical factors and surgical technique. This device is limited by Federal (or United States) law to investigational use.
Participating in the Clinical Study
This study is designed to collect data on the safety and effectiveness of the Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis investigational device. Participation includes a screening process to assess eligibility, surgery if enrolled, and scheduled follow-ups. Participation is voluntary and not all individuals will qualify.
Find a Participating Study SiteContacting a site does not imply eligibility or enrollment.
Participating in the Clinical Study
This study is designed to collect data on the safety and effectiveness of the Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis investigational device. Participation includes a screening process to assess eligibility, surgery if enrolled, and scheduled follow-ups.
Find a Participating Study SiteContacting a site does not imply eligibility or enrollment.
Frequently Asked Questions
- What is the purpose of this clinical study?
The purpose is to evaluate the safety and effectiveness of the Infla10® Pulse™ Dynamic Inflatable Penile Prosthesis for men who may be candidates for penile prosthesis implantation.
- What is an investigational device?
An investigational device is one that is permitted by the FDA for use in a clinical study to gather data on its safety and effectiveness. It is not yet approved for commercial sale in the United States. This device is limited by Federal (or United States) law to investigational use.
- How is patient privacy protected?
Data will be handled under IRB oversight and applicable regulations. Do not submit personal health information through this website outside designated study forms.
- What does "bench testing" mean?
Bench testing refers to laboratory evaluations conducted under controlled conditions to assess the mechanical properties and design specifications of the device. These tests are not predictive of individual clinical outcomes.
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.