Evaluation of the Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis for the Treatment of Patients With Erectile Dysfunction

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 1 month, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: f
View:

• Male ≥21 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 follow-up visits and tests.

Locations
Other Locations
Turkey
SBU Diskapi Yildirim Beyazit Training and Research Hospital
RECRUITING
Ankara
Haydarpasa Numune Training and Research Hospital
RECRUITING
Istanbul
Kavacik Medistate Hospital
RECRUITING
Istanbul
Contact Information
Primary
Orhan Koca, MD
drorhankoca@hotmail.com
+90 532 562 15 13
Backup
Metin Ishak Ozturk, MD
drmetinozturk@gmail.com
+90 532 245 94 17
Time Frame
Start Date: 2022-07-11
Estimated Completion Date: 2026-05-21
Participants
Target number of participants: 177
Treatments
Other: Experimental: Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis Group
Male subjects 21 years of age and older who are implanted with an Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for erectile dysfunction.
Related Therapeutic Areas
Sponsors
Leads: Rigicon, Inc.

This content was sourced from clinicaltrials.gov