A new clinical trial evaluating the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for the treatment of erectile dysfunction (ED) is set to begin. Sponsored by Rigicon, Inc., the trial represents a critical step in assessing the device’s safety and effectiveness. Professionals in clinical, quality, and regulatory domains may find this development particularly relevant.
In this article:
- What is the Rigicon Infla10® Inflatable Penile Prosthesis?
- Key Details of the Trial
- Implications for Clinical and Regulatory Teams
What is the Rigicon Infla10® Inflatable Penile Prosthesis?
The Rigicon Infla10® is a medical device designed to assist patients with moderate to severe erectile dysfunction. It functions as a three-piece inflatable penile prosthesis, providing a surgical solution to restore erectile function. Devices like this are often recommended when non-surgical treatments prove ineffective.
The Rigicon Infla10® is intended to offer both patients and clinicians a durable and reliable option for managing erectile dysfunction. The clinical trial will provide data to validate its safety, effectiveness, and long-term performance.
Key Details of the Trial
According to a recent update published on December 12, 2025, the study is listed as “Not yet recruiting.” The trial is sponsored by Rigicon, Inc., and will focus specifically on evaluating the Rigicon Infla10® for its intended therapeutic use in erectile dysfunction.
While official recruitment timelines have not been disclosed, this trial is expected to adhere to stringent clinical and regulatory protocols. Participants will undergo pre- and post-implementation assessments to provide reliable data on safety outcomes, efficacy, and patient satisfaction.
The trial is critical for compliance with regulatory standards and could influence the broader market introduction for this device, depending on the study’s findings.
Implications for Clinical and Regulatory Teams
Professionals working in clinical and regulatory affairs should monitor this trial closely. Regulatory compliance, patient safety, and performance all depend heavily on well-conducted clinical trials. These findings will shape decision-making in areas like product validation, market access, and post-market surveillance.
Moreover, understanding the trial’s design and outcomes will be key for teams involved in quality assurance and device lifecycle management. Data from the trial will also guide procedural training for healthcare providers aiming to offer this device as a treatment solution.
FAQ
- What condition does the Rigicon Infla10® target?
The device is intended for the treatment of erectile dysfunction in patients where other therapies have proven ineffective. - Who is sponsoring this clinical trial?
The trial is sponsored by Rigicon, Inc. - When will recruitment for the trial begin?
As of December 12, 2025, the trial is listed as “Not yet recruiting,” with further updates expected soon. - How does this trial affect regulatory and quality processes?
Clinical trial data is essential for product validation, regulatory approval, and ensuring patient safety and satisfaction.
Conclusion
The clinical evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis marks an important milestone in advancing treatment options for erectile dysfunction. Clinical, quality, and regulatory teams should stay informed about the study’s progression and findings to ensure alignment with evolving standards for safety and efficacy.
Disclaimer
This information is provided for professional purposes. It does not constitute legal or regulatory advice. Consult appropriate guidelines for compliance requirements.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07273773?term=medical+device