| CTRI Number |
CTRI/2021/03/031852 [Registered on: 09/03/2021] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to analyze the safety and effectiveness of Intra Cath-2 (I.V Cannula) during infusion therapy in Indian population |
|
Scientific Title of Study
|
A prospective, single arm, post market clinical follow-up of Intra Cath-2 (I.V Cannula) to explore safety and performance in Indian population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RGI/CRO/CIP (IVC), 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 Comples,
Pushpanjali Hospital & Research Center Pvt. Ltd.
Pushpanjali Palace, Delhi Gate,
Agra
UTTAR PRADESH
282002
India |
| Phone |
9628273135 |
| Fax |
|
| Email |
dr.rohithjain85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Anand Mohan |
| Designation |
Clinical Research Associate |
| 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-282006 (India)
Agra
UTTAR PRADESH
Agra
UTTAR PRADESH
282006
India |
| Phone |
8574610157 |
| Fax |
|
| Email |
cro@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-282006 (India)
Agra
UTTAR PRADESH
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 |
Pushpanjali Hospital & Research Center Pvt Ltd
Puspanjali Palace, Delhi Gate
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: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra Cath-2 (I.V Cannula) |
The device Intra Cath-2 (I.V Cannula) is an intravenous access device required for intravenous infusion therapy |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and Females above 18 year expected to require intravenous peripheral infusion therapy.
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.Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc.
3.Allergy with any of the material of Intra Cath-2 (I.V Cannula) and its component.
4.Subject who is pregnant or breastfeeding.
5. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital.
6.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 |
1. Less than 3 Days
2. Greater than 3 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)
|
15/03/2021 |
| Date of Study Completion (India) |
27/04/2024 |
| 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)
|
Not Applicable |
| 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, post marketing clinical follow-up of Intra Cath-2 (Intravenous (IV) Cannula) to explore safety and performance in subject who requiring intravenous peripheral infusion therapy.
Inclusion Criteria:-
1. Males and Females above 18 year expected to require intravenous peripheral infusion therapy. 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. Subject, who cannot provide informed consent such as unconscious, mentally challenged subject, etc. 3. Allergy with any of the material of Intra Cath-2 (I.V Cannula) and its component. 4. Subject who is pregnant or breastfeeding. 5. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. 6. Participation in another research study involving an active investigation within 30 days prior to consent. |