An interventional study to evaluate the safety and performance of bovine pericardial tissue patch use in Peyronie’s disease.
Not Applicable
- Conditions
- Health Condition 1: N52- Male erectile dysfunction
- Registration Number
- CTRI/2024/07/070277
- Lead Sponsor
- Tisgenx, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients with disabling penile curvature
2. Tunical plaques in patients with Peyronie’s disease
3. Willingness to participate and provide informed consent
Exclusion Criteria
1. Patients requiring prostheses
2. Congenital penile curvature
3. Patients with constriction bands, unilateral indentations, and hourglass deformities
4. Patients with known allergies to bovine products or pre-existing conditions contraindicating the
use of bovine pericardial patches.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Safety: Incidence of adverse events related to the use of bovine pericardial patch, including <br/ ><br>infections, thrombosis, and allergic reactions. <br/ ><br>• Efficacy: Patency rates of the grafts assessed through clinical photos of erection at specified <br/ ><br>follow-up intervals.Timepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term <br/ ><br>outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 <br/ ><br>months and 1 year.
- Secondary Outcome Measures
Name Time Method • Patients will be examined post-surgery by evaluating the ability to perform successful sexual <br/ ><br>intercourse, improvements in curvature, and satisfaction with treatment <br/ ><br>• Patch handling and characteristicsTimepoint: The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term <br/ ><br>outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6 <br/ ><br>months and 1 year.