| CTRI Number |
CTRI/2025/01/079365 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
The Bovine Pericardial Tissue Patch is intended for use as a
surgical patch for cardiac and vascular reconstruction and
repair, soft tissue deficiency reconstruction and repair, and
reinforcing the suture line during general surgical procedures. |
|
Scientific Title of Study
|
A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch in Vascular Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robbie K George |
| Designation |
HOD & Senior Consultant - Vascular and Endovascular Surgery |
| Affiliation |
Mazumdar Shaw Medical Center- a unit of Narayana Health |
| Address |
Mazumdar Shaw Medical Center - A unit of Narayana Health
No. 258/A Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9538896751 |
| Fax |
|
| Email |
robbie.george.dr@narayanahealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Robbie K George |
| Designation |
HOD & Senior Consultant - Vascular and Endovascular Surgery |
| Affiliation |
Mazumdar Shaw Medical Center- a unit of Narayana Health |
| Address |
Mazumdar Shaw Medical Center - A unit of Narayana Health
No. 258/A Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bengaluru
KARNATAKA
560099
India |
| Phone |
9538896751 |
| Fax |
|
| Email |
robbie.george.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Robbie K George |
| Designation |
HOD & Senior Consultant - Vascular and Endovascular Surgery |
| Affiliation |
Mazumdar Shaw Medical Center- a unit of Narayana Health |
| Address |
Mazumdar Shaw Medical Center - A unit of Narayana Health
No. 258/A Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bengaluru
KARNATAKA
560099
India |
| Phone |
9538896751 |
| Fax |
|
| Email |
robbie.george.dr@narayanahealth.org |
|
|
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 Equipment Manufacturing] |
|
|
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 Robbie K George |
Mazumdar Shaw Medical Center - A unit of Narayana Health |
No. 258/A Bommasandra Industrial Area, Anekal Taluk, Hosur Road
Bengaluru, Karnataka 560099, India
Bangalore
KARNATAKA |
9538896751
robbie.george.dr@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| narayana health medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I73||Other peripheral vascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bovine Pericardial Tissue Patch |
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. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 years and older undergoing vascular surgery requiring a patch graft. |
|
| ExclusionCriteria |
| Details |
1.Patients with known allergies to bovine products or pre-existing conditions contraindicating the
use of bovine pericardial patches.
2.Patients with uncontrolled infections
3.Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Safety: Incidence of adverse events related to the use of bovine pericardial patch, including
infections, thrombosis, and allergic reactions.
2.Efficacy: Patency rates of vascular grafts assessed through imaging studies - Doppler ultrasound
at specified follow-up intervals.
3.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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Patients will be examined post-surgery by evaluating the occurrence of wound infection,
hematoma, partial thrombosis, thrombotic occlusion, pseudoaneurysm, stroke, myocardial
infarction, carotid artery thrombosis, paralysis, restenosis
2.Mortality rate. |
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/02/2025 |
| 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="1"
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
|
A PMCF study to evaluate the safety and efficacy of the Bovine Pericardial Tissue Patch in Vascular Surgeries. Study Design-The study will be single centric, prospective, interventional clinical study. Primary Objectives: • Safety: Incidence of adverse events related to the use of bovine pericardial patch, including infections, thrombosis, and allergic reactions. • Efficacy: Patency rates of vascular grafts assessed through imaging studies - Doppler ultrasound at specified follow-up intervals. • Patch handling and characteristics Secondary Objectives: • Patients will be examined post-surgery by evaluating the occurrence of wound infection, hematoma, partial thrombosis, thrombotic occlusion, pseudoaneurysm, stroke, myocardial infarction, carotid artery thrombosis, paralysis, restenosis • Mortality rate. Subject Types The study population will consist of subjects in the following group: - Patients scheduled for vascular surgery requiring a patch graft. Population and Enrolment A total of 15 subjects will be recruited for the study of the product Bovine Pericardial Tissue Patch for vascular surgery. Inclusion and Exclusion criteria Inclusion Criteria • Adults aged 18 years and older undergoing vascular surgery requiring a patch graft. Exclusion Criteria • Patients with known allergies to bovine products or pre-existing conditions contraindicating the use of bovine pericardial patches • Patients with uncontrolled infections • Pregnant patients. Duration of Data collection The duration of data collection will be 1 year |