| CTRI Number |
CTRI/2024/06/068248 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post-market clinical follow-up study for flowable gelatin haemostatic matrix kit in real-world patients to stop bleeding during surgery |
|
Scientific Title of Study
|
A prospective, open label, multi-center, single-arm, observational post-market clinical follow-up study to evaluate the safety and performance of flowable gelatin haemostatic matrix kit in real-world patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AL/PMCFP/FGHM/R0 version 00 dated 15/01/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Antariksh Waghmare |
| Designation |
Orthopedic Surgeon |
| Affiliation |
Shri Shankaryacharya Institute of Medical Science and Hospital |
| Address |
Department of OBG and Gynec, Ground Floor gynec OPD, Shri shankaracharya institute of medical sciences, junwani road Bhilai Durg Chhattisgarh 490020
Durg
CHHATTISGARH
490020
India |
| Phone |
9096053960 |
| Fax |
- |
| Email |
antariksh373@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Piyush Patel |
| Designation |
Quality Head |
| Affiliation |
Aegis Lifesciences Private Limited |
| Address |
Aegis Lifesciences Private Limited, 215/216 Mahagujarat Ind. Estate, Ahmadabad.
Ahmadabad
GUJARAT
382213
India |
| Phone |
9898791189 |
| Fax |
|
| Email |
qc.aegis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Piyush Patel |
| Designation |
Quality Head |
| Affiliation |
Aegis Lifesciences Private Limited |
| Address |
Aegis Lifesciences Private Limited, 215/216 Mahagujarat Ind. Estate, Ahmadabad.
GUJARAT
382213
India |
| Phone |
9898791189 |
| Fax |
|
| Email |
qc.aegis@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aegis Lifesciences Pvt. Ltd. 215/216, Mahagujarat Industrial Estate, Sarkhej-Bavla Road, Moraiya, Ta: Sanand, Dist.: Ahmedabad – 382213, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Aegis Lifesciences Private Limited |
| Address |
Aegis Lifesciences Pvt. Ltd. 215/216, Mahagujarat Industrial Estate, Sarkhej-Bavla Road, Moraiya, Ta: Sanand, Dist.: Ahmedabad – 382213, Gujarat, India |
| Type of Sponsor |
Other [Medical device manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhinav Bhatnagar |
Abhinav Multispecialty Hospital Pvt. Ltd. |
Abhinav Multispecialty Hospital, First floor, Room no. 1, Orthopedic department 10 no. puliya opp swastik school lashari Bagh Nagpur Maharashtra - 440017
Nagpur
MAHARASHTRA |
0712-2641715
-
b_abhinav@hotmail.com |
| Dr Antariksh Waghmare |
Shri shankaracharya Institute of medical sciences |
Department of OBG and Gynec, Ground Floor gynec OPD, Shri shankaracharya institute of medical sciences, junwani road Bhilai Durg Chhattisgarh 490020
Durg
CHHATTISGARH |
909653960
-
antariksh373@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Shankaracharya Institute of Medical Sciences Junwani Bhilai Junwani Durg Chhattisgarh - 490020 India |
Approved |
| Jasleen Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. A Patient requiring haemostasis in surgical procedures where
control of bleeding by standard surgical techniques is ineffective
or impractical.
2. A Patient or their legally designated guardian is willing to sign
Informed Consent Form (ICF)
3. A Patient willing to comply with the requirements given in ICF
including the requirements for participating till last follow-up.
4. All patients who are not allergic to gelatin. |
|
| ExclusionCriteria |
| Details |
1. A Patient currently participating in another clinical study.
2. A Patient having known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombasthenia,
haemophilia, or Von Willebrand disease)
3. A Patient having allergy to porcine gelatin
4. A Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating.
5. A Patient undergoing ophthalmic surgery.
6. A Patient requiring closure of skin incisions by Flogel because it
may interfere with the healing of skin edges.
7. A Patient requiring haemostasis in intravascular compartments because of the risk of embolization.
8. A Patient requiring hemostasis in the absence of active blood flow e.g. while the vessel is clamped or bypassed as it may result
in risk of intravascular clotting from intravascular injection.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Haemostasis Rate:
Time to Haemostasis (TTH): Time required to achieve haemostasis after application of the FLOGEL
2)Absorption: Determination of absorption of flowable gelatin haemostatic matrix through medical imaging techniques after 4 weeks (28 days) of its implantation. |
Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Determination of safety
• Determination of complications associated with FLOGEL.
• Determination of events of re-bleeding (leading to blood-transfusion) or re-operation after achieving haemostasis.
Device Handling Characteristics:Determination of handling characteristics of flowable gelatin haemostatic matrix during its implantation.
|
Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
12/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Clinical Study Report
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) - For any type of research
- By what mechanism will data be made available?
Response (Others) - at CTRI site
- For how long will this data be available start date provided 26-11-2024 and end date provided 26-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Study Design: Prospective, open-label, multi-center, single-arm, observational, post-market clinical follow-up study Study Population: Patients, irrespective of age and gender, requiring haemostasis in
surgical procedures [e.g. abdominal, anorectal, dental, ENT, Genitourinary, gynecological, hysterectomy, neurosurgery, Orthopaedic,
Otolaryngological, partial nephrectomy, plastic surgery,
cardiovascular, spinal, tumor surgery, hepatic] when control of
bleeding by standard surgical haemostatic techniques is ineffective
or impractical. However, the use of FLOGEL has not been established
in the patients with known allergies to the gelatin, children and
pregnant women. Number of Subjects: Considering 10% possible loss to follow-up, a minimum of 100 subjects will be enrolled. Number of Study Sites: Minimum 2 sites Subject Device: FLOGEL® [Flowable Gelatin Haemostatic Matrix Kit] Study Duration: 60 days Study Procedure: Study sites will be responsible for screening of patients, conducting
their informed consent process and conducting this study as per
local regulatory requirements. Patients, upon enrolment on meeting
eligibility criteria, will be participating in this study till the last followup (Day 60).
Clinical data collected throughout the trial will be recorded in Case
Report Form (CRF). The data will be analyzed by data management
team of a third-party CRO (Contract Research Organization).
Monitoring of this study will be performed by representatives of
Aegis Lifesciences Pvt. Ltd.
Study Schedule: Study schedule includes pre-operative evaluation, operative day (0 day) and three follow-ups. The follow-up days will include 2nd day, 28th day and 60th day after surgery |