| CTRI Number |
CTRI/2021/04/032495 [Registered on: 01/04/2021] Trial Registered Prospectively |
| Last Modified On: |
12/02/2024 |
| 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 Bi-Valve (Three-way Stop Cock) used with infusion line and pressure monitoring in Indian Population. |
|
Scientific Title of Study
|
A prospective, single-arm, post-market clinical follow-up of Bi-Valve (Three-way stop cock) to explore safety and performance in Indian population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RGI/CRO/CIP (Bi-Valve), Version 2.0, Dated 05 Aug 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Jain |
| Designation |
Principal Investigator |
| Affiliation |
Pushpanjali Hospital & Research Center Pvt. Ltd. |
| Address |
Room No. 02, Second Floor OPD, Complex, Puspanjali Hospital & Reserch Center Pvt. Ltd. Pushpanjali Palace, Delhi Gate, Agra
Agra
UTTAR PRADESH
282002
India |
| Phone |
9628273135 |
| Fax |
|
| Email |
dr.rohitjain85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Gagan Chooramani |
| Designation |
Clinical Trial Assistant |
| Affiliation |
Romsons Scientific & Surgical Industries Pvt. Ltd. |
| Address |
352, Clinical Research Operations, First Floor,Romsons Scientific & Surgical Industries Pvt. Ltd. 63-64, Industrial Estate, Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
9389319931 |
| Fax |
|
| Email |
cta2@romsons.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vijay Arora |
| Designation |
Manager-Regulatory Affairs |
| Affiliation |
Romsons Scientific & Surgical Industries Pvt. Ltd. |
| Address |
274, Regulatory affairs, First Floor, Romsons Scientific & Surgical Industries Pvt. Ltd. 63-64, Industrial Estate, Nunhai
Agra
UTTAR PRADESH
282006
India |
| Phone |
8433296719 |
| Fax |
|
| Email |
regulatory2@romsons.com |
|
|
Source of Monetary or Material Support
|
| Romsons Scientific and Surgical Industries Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Romsons Scientific and Surgical Industries Pvt Ltd |
| Address |
63-64, Industrial Estate, Nunhai, Agra- 282006 (India) |
| Type of Sponsor |
Other [Medical Device Manufacturer-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 Rohit Jain |
Pushpanjali Hospital & Research Center Pvt. Ltd. |
Room No. 02, Second Floor, OPD Complex
Agra
UTTAR PRADESH |
9628273135
dr.rohitjain85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pushpanjali Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z69-Z76||Persons encountering health services in other circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bi-Valve (Three-way stop cock) |
Bivalve (Three-Way Stop Cock) is intended for use with infusion line for the selective running of one or two paths intravenous line also used for pressure monitoring. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc.
2.Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process.
3.The subject is willing and able to comply with the requirement of the follow-up.
|
|
| ExclusionCriteria |
| Details |
1.Subject who present with medical emergency, where treatment is more priority than the informed consent process.
2.Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids.
3.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
4.Any known allergy of material of Three-way stop cock and its component.
5.Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the protocol.
6.Subject who is pregnant or breastfeeding.
7.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
8.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 |
| Successful completion of performance timeline |
Not Beyond 5 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/04/2021 |
| Date of Study Completion (India) |
10/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Published |
|
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, single arm, post-market clinical follow-up of Bi-Valve (Three-way stop cock) to explore safety and performance in Indian population.
Inclusion Criteria 1. Males and Females above 18 years who are expected to require simultaneous infusions, intermittent drug injections, blood samplings, central venous pressure measurements, arterial add-on devices used for invasive pressure measurements, blood sampling/s, flushing with normal saline, etc. 2. Subject who can provide informed consent form in writing and medically in a position to undergo consent and screening process. 3. The subject is willing and able to comply with the requirement of the follow-up.
Exclusion Criteria
1. Subject who present with medical emergency, where treatment is more priority than the informed consent process. 2. Any planned therapy of corrosive medications, photosensitive medication and highly viscous fluids. 3. Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc. 4. Any known allergy of material of Three-way stop cock and its component. 5. Other conditions, which in the opinion of investigators make the subject unsuitable for enrolment or could, interfere with his participation in, and completion of the protocol. 6. Subject who is pregnant or breastfeeding. 7. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 8. Participation in another research study involving an active investigation within 30 days prior to consent.
|