| CTRI Number |
CTRI/2024/01/061742 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate safety and performance of absorbable, gelatin-based hemostat in patients undergoing different types of surgeries. |
|
Scientific Title of Study
|
Prospective, multi-center, single-arm, interventional, post-market clinical study to evaluate safety and performance of absorbable, gelatin-based hemostat in patients undergoing abdominal, anorectal, dental, ENT, Genito-urinary, gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery when controlling bleeding by standard surgical techniques is ineffective and/or impractical |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AL/PMCFP/AGS/R0 |
Protocol Number |
| Version 1.0 dated 08 May 2023 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Peeyusha Wadhwani Rajani |
| Designation |
Principal Investigator |
| Affiliation |
Medical Care Centre and Hospital |
| Address |
Medical Care Centre and Hospital, Laxmi Complex, Kanpur road, Alambagh
Lucknow
UTTAR PRADESH
226005
India |
| Phone |
9879978135 |
| Fax |
|
| Email |
peeyusha3891@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atonu Dutta |
| Designation |
Chief Executive Officer |
| Affiliation |
Alceon Medtech Consulting |
| Address |
1001-1005 Ocean Sarabhai Compound, Alkapuri, Vadodara
Vadodara
GUJARAT
390023
India |
| Phone |
9925023428 |
| Fax |
|
| Email |
atonu.dutta@alceonconsulting.com |
|
Details of Contact Person
Public Query
|
| Name |
Atonu Dutta |
| Designation |
Chief Executive Officer |
| Affiliation |
Alceon Medtech Consulting |
| Address |
1001-1005 Ocean Sarabhai Compound, Alkapuri, Vadodara
Vadodara
GUJARAT
390023
India |
| Phone |
9925023428 |
| Fax |
|
| Email |
atonu.dutta@alceonconsulting.com |
|
|
Source of Monetary or Material Support
|
| Alceon Medtech Consulting
1001-1005 Ocean Sarabhai Compound Alkapuri, Vadodara Gujarat 390023 |
|
|
Primary Sponsor
|
| Name |
Aegis Lifesciences Pvt. Ltd. |
| Address |
215/216 Mahagujarat Industrial Estate, Ahemdabad, Gujarat-382213 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Peeyusha Wadhwani Rajani |
Medical Care Centre and Hospital |
First Floor Department of Gynecology OPD Room of Dr Peeyusha Rajanai Laxmi Complex Kanpur Road Alambagh
Lucknow
UTTAR PRADESH |
9879978135
peeyusha3891@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| EthicsCommitteeGSVMMedicalCollege |
Approved |
| Institutional Ethics Committee Medical Care Centre & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L949||Localized connective tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient is 18 years of age or older
2. The patient will undergo one or more of the following procedures: abdominal, anorectal, dental, ENT, Genito-urinary,gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery
3. Patient or their guardian is willing to sign Informed Consent Form (ICF)
4. Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up |
|
| ExclusionCriteria |
| Details |
Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care) or is lactating
Patient is allergic to collagen derived products or any other materials used in absorbable gelatine sponge and powder
Patient has an active infection at the surgical site
The use of hemostat is contraindicated for the patient
Patient has known bleeding disorder (including thrombocytopenia (less than 100000 platelet count) thrombasthenia hemophilia or von Willebrand disease)
Patient has received antibiotic solutions or powders at the intended application site
Patient has undergone surgery at the intended application site less than or equal to 6 months before the current surgical procedure
Patient is unavailable for followup
Patient is currently participating in another clinical study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery
Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder
|
Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery
Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemostatic Handling Characteristics (Surgeon s Questionnaire) Time Frame Day 0 Surgery
Determination of handling characteristics of absorbable gelatine sponge and powder during implantation
Liquefication Time Frame Day 5 post procedure
Determination of initiation of absorption of absorbable gelatine sponge and powder through radiological examination after 5 days of its implantation
Absorption Time Frame Day 28 post procedure]
Determination of complete absorption of absorbable gelatine sponge and powder through radiological examination after 28 days of its implantation
Determination of safety Time Frame Procedure up to 60 days post procedure]
Evaluation of rate of incidence due to the implantation of absorbable gelatine sponge and powder
|
Day 0 Day 5 Day 28 Day 60 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
26/01/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
To evaluate safety and
performance of absorbable, gelatin based hemostat in patients undergoing abdominal,
anorectal dental ENT Genitourinary gynecological
hysterectomy, neurosurgery orthopaedic otolaryngological, partial
nephrectomy, plastic surgery cardiovascular spinal, tumor surgery hepatic
or ophthalmic surgery when controlling bleeding by standard surgical techniques
is ineffective and or impractical The study will be conducted in
compliance with local regulatory requirements. An Independent Ethics Committee will review and approve study related
documents prior to patient enrolment. Patients will be screened as per
pre-defined eligibility criteria. Patients who meet eligibility criteria will
be explained the study procedure by principal investigator. Patients will sign
informed consent before participating in the study |