| CTRI Number |
CTRI/2024/02/062232 [Registered on: 02/02/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To explore safety and performance of Closed Wound Drainage System in Adult & Paediatric subjects in Indian Population. |
|
Scientific Title of Study
|
A prospective, single arm, post market clinical follow-up of Closed Wound Drainage System to explore its safety and performance in Adult & Paediatric subjects in Indian Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RG/CRO/CIP (CWDS), Version 3.0, Dated 01 June 2023. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Srivishnu |
| Designation |
Surgical Oncologist |
| Affiliation |
Valentis Cancer Hospital |
| Address |
Room No 3 Ground Floor Valentis Cancer Hospital Mussoorie Mawana Road
Meerut
UTTAR PRADESH
250001
India |
| Phone |
9677178978 |
| Fax |
|
| Email |
dr.vishnu008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Saurabh Dwivedi |
| Designation |
Clinical Trial Assistant |
| Affiliation |
Romsons Group Private Limited |
| Address |
First Floor, Regulatory Department, 63-64, Industrial Estate, Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
9971256314 |
| Fax |
|
| Email |
cta1@romsons.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop Batra |
| Designation |
Senior Manager- Regulatory Affairs |
| Affiliation |
Romsons Group Private Limited |
| Address |
First Floor, Regulatory Department, 63-64, Industrial Estate, Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
9258105266 |
| Fax |
|
| Email |
regulatory2b@romsons.com |
|
|
Source of Monetary or Material Support
|
| Romsons Group Private Limited, 63-64, Industrial Estate, Nunhai, Agra-282006, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Romsons Group Private Limited |
| Address |
63-64, Industrial Estate, Nunhai, Agra |
| 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 S Srivishnu |
Valentis Cancer Hospital |
Room No 3 Ground Floor Valentis Cancer Hospital Mussoorie, Mawana Road
Meerut
UTTAR PRADESH |
9677178978
dr.vishnu008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Valentis Cancer Hospital |
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 |
NA |
NA |
| Intervention |
Romo Vac Set (GS-5002, GS-5002F, GS-5002M, GS-5002S, GS-5002N), Mini Vac Set (GS-5006), Flat Drain Set (GS-5047), Redon Drain Catheter (GS-5004) |
Device maximum use duration is not more than 7 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Males and Females Adult & Paediatric who are expected to undergo surgery closed wound drainage procedures
2 The subject who is willing and able to comply with the requirement of the follow-up OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who is willing and able to comply with the requirement of the follow-up.
3 Subject who can provide Informed Consent Form Adult in writing and medically in a position to undergo consent and screening process OR in case of Paediatrics parent of child LAR Legally Acceptable Representative can provide Informed Assent Form Child
|
|
| ExclusionCriteria |
| Details |
1 Subject who present with medical emergency where treatment is more priority than the informed consent process informed assent process
2 Subject who cannot provide Informed Consent Form Adult such as unconscious mentally challenged subject OR in case of Paediatrics parent of child LAR Legally Acceptable Representative who cannot provide Informed Assent Form Child or give permission etc
3 Any known allergy with any of the material of Closed Wound Drainage System and its components
4 Other conditions which in the opinion of investigators make the patient unsuitable for enrollment or could interfere with his her participation in and completion of the clinical investigation plan protocol
5 Subject who is pregnant or breastfeeding
6 Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital
7 Participation in another research study involving an active investigation within 30 days prior to consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Primary End Point of the study are as
1 Intended for Closed Wound Drainage
2 Facilitating drainage from the Closed wound site by catheter
3 Angulated sharp tipped trocar needle for easy penetration and placement of drainage catheter
4 Application of optimum negative pressure by flexible bellow jar chamber
5 Facilitating the precise drained volume determination in follow-up from closed wound
6 Improving the quality of life by reduction of symptoms
7 Achieving the intended clinical purpose |
Device maximum use duration is not more than 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Secondary End Point of the study are as
1 Device material compatibility with the tissue and body fluids
2 Durability Sustainability of device during placement & intended clinical performance
3 Proper fixation fitment of the device accessories |
Device maximum use duration is not more than 7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/02/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This is a prospective, post marketing clinical follow-up
of Closed Wound Drainage System to evaluate its safety and performance in
subjects who will undergo surgery/ closed wound drainage procedures.
Investigators and their team will be responsible for recruitment and ethical
conduct of the follow-up. As per inclusion-exclusion criteria, subjects will be
included in this follow-up. An informed consent / informed assent will be
obtained from all subjects who are potential candidates prior to commencement
of any follow-up related procedure. All data will be
collected in the follow-up specific Case Report Form. |