| CTRI Number |
CTRI/2024/08/071956 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety and performance of the Bovine Pericardial Tissue Patch |
|
Scientific Title of Study
|
A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TP-756-18 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal V Bhende |
| Designation |
Consultant, Congenital and Pediatric Cardiac Surgeon |
| Affiliation |
Bhanubhai and Madhuben Patel Cardiac Centre |
| Address |
First floor, Room No.3,
Department: Cardiology
Gokal Nagar, Karamsad, Anand, Gujarat, India
Anand
GUJARAT
388345
India |
| Phone |
07708997222 |
| Fax |
|
| Email |
drvishalbhende@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishal V Bhende |
| Designation |
Consultant, Congenital and Pediatric Cardiac Surgeon |
| Affiliation |
Bhanubhai and Madhuben Patel Cardiac Centre |
| Address |
First floor, Room No.3,
Department: Cardiology
Gokal Nagar, Karamsad, Anand, Gujarat, India
GUJARAT
388345
India |
| Phone |
07708997222 |
| Fax |
|
| Email |
drvishalbhende@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal V Bhende |
| Designation |
Consultant, Congenital and Pediatric Cardiac Surgeon |
| Affiliation |
Bhanubhai and Madhuben Patel Cardiac Centre |
| Address |
First floor, Room No.3,
Department: Cardiology
Gokal Nagar, Karamsad, Anand, Gujarat, India
GUJARAT
388345
India |
| Phone |
07708997222 |
| Fax |
|
| Email |
drvishalbhende@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 Vishal V Bhende |
Bhanubhai and Madhuben Patel Cardiac Centre |
First floor, Room No.3,
Department: Cardiology
Gokal Nagar, Karamsad, Anand, Gujarat - 388345, India
Anand
GUJARAT |
9845383405
drvishalbhende@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHAIKAKA UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
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: Administration of bovine pericardial patch during cardiac surgery for intracardiac or extracardiac
repair.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing cardiac surgery requiring a patch for intracardiac or extracardiac repair. |
|
| ExclusionCriteria |
| Details |
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 |
1. To assess the patch performance in terms of preoperative imaging, surgical handling, postoperative outcomes and follow-up echocardiography
2. To study the safety in terms of Patch-related complication and Intra & postoperative complications
|
Postoperatively:
1. 1 month
2. 3rd month
3. 6th month
4. Last Follow-up 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effectiveness of the Bovine Pericardial Tissue Patch Handling characteristics, Patient outcome: ICU days, Hospital days, follow-up echo for cardiac surgery patients to look for
patch integrity & Mortality & reoperation rates |
Postoperatively:
1. 1 month
2. 3rd month
3. 6th month
4. Last Follow-up 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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 undergoing cardiac surgery requiring a patch for intracardiac or extracardiac repair; willing to participate and provide informed consent will be recruited for the study after meeting the inclusion criteria. Intervention planned: Administration of bovine pericardial patch during cardiac surgery for intracardiac or extracardiac repair. Comparison: Pre and post operative ECHO and clinical assessment of cardiac surgery patients. Data Collection: Data will be collected through medical records, intraoperative observations, postoperative follow-up visits, and imaging studies. Patient demographics, preoperative conditions, and intraoperative details will be documented. Adverse events and complications will be systematically recorded and graded. |