| CTRI Number |
CTRI/2024/07/070277 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An interventional study to evaluate the safety and performance of bovine pericardial tissue patch use in Peyronie’s disease. |
|
Scientific Title of Study
|
Assessing outcomes following penile corrective surgeries using bovine pericardial patch: A prospective cohort study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Doc. No: TP-756-21, Rev: R00, Date: 22.04.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Joshi |
| Designation |
Consultant Genitourinary Reconstructive Specialist |
| Affiliation |
Urokul Hospital |
| Address |
Urology Department,
Floor No. 01, Room No. 03, Mohan Nagar Cooperative Society, Baner, Pune.
Pune
MAHARASHTRA
411045
India |
| Phone |
9923406464 |
| Fax |
|
| Email |
drpankajmjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Joshi |
| Designation |
Consultant Genitourinary Reconstructive Specialist |
| Affiliation |
Urokul Hospital |
| Address |
Urology Department,
Floor No. 01, Room No. 03, Mohan Nagar Cooperative Society, Baner, Pune.
MAHARASHTRA
411045
India |
| Phone |
9923406464 |
| Fax |
|
| Email |
drpankajmjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Joshi |
| Designation |
Consultant Genitourinary Reconstructive Specialist |
| Affiliation |
Urokul Hospital |
| Address |
Urology Department,
Floor No. 01, Room No. 03, Mohan Nagar Cooperative Society, Baner, Pune.
MAHARASHTRA
411045
India |
| Phone |
9923406464 |
| Fax |
|
| Email |
drpankajmjoshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tisgenx, Inc.
15615 Alton Parkway, Suite 450
Irvine, CA 92618 |
|
|
Primary Sponsor
|
| Name |
Tisgenx, Inc. |
| Address |
15615 Alton Parkway, Suite 450 Irvine, CA 92618 |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj Joshi |
Urokul Hospital |
Urology Department, Floor No: 01, Room No: 03,
Plot No: 61/2/1, 11/1, Mumbai Pune Bypass Rd,
next to Bitwise Terratower, Mohan Nagar Co-Op Society, Baner
Pune
MAHARASHTRA |
9923406464
drpankajmjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N52||Male erectile dysfunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bovine Pericardial Tissue Patch |
Tisgenx’s BPT Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinforcing the suture line during general surgical procedures. The BPT patch can be sutured into blood vessels/shaped into different forms at the discretion of the physician. A variety of sizes and tapered models are available but may also be tailored by the surgeon if required. Intervention planned: Plaque incision and grafting of the defect with bovine pericardium for patients with Peyronie’s disease.
Total duration of intervention is 1 year. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients with disabling penile curvature
2. Tunical plaques in patients with Peyronie’s disease
3. Willingness to participate and provide informed consent |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
infections, thrombosis, and allergic reactions.
• Efficacy: Patency rates of the grafts assessed through clinical photos of erection at specified
follow-up intervals. |
The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term
outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6
months and 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Patients will be examined post-surgery by evaluating the ability to perform successful sexual
intercourse, improvements in curvature, and satisfaction with treatment
• Patch handling and characteristics |
The study will follow up with patients for a minimum of 1 month postoperatively to evaluate short-term
outcomes. Long-term outcomes will also be assessed during subsequent follow-up periods, 3 months, 6
months and 1 year. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be single centric, prospective, interventional clinical study. Patients with Peyronie’s disease, requiring penile corrective surgery using bovine pericardium graft; willing to participate and provide informed consent will be recruited for the study after meeting the inclusion criteria. Intervention planned: Plaque incision and grafting of the defect with bovine pericardium for patients with Peyronie’s disease. Comparison: Pre and post-operative Penile Curvature, erectile dysfunction will be assessed clinically. Data Collection: Data will be collected through medical records, intraoperative observations, postoperative follow-up visits, and clinical photos of erection. Patient demographics, preoperative conditions, and intraoperative details will be documented. Adverse events and complications will be systematically recorded and graded. |