| CTRI Number |
CTRI/2024/02/063337 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| 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 Infant Feeding Tube (Feedy) in paediatric subjects in Indian population. |
|
Scientific Title of Study
|
A prospective, single arm, post market clinical follow-up of Infant Feeding Tube (Feedy) to explore safety and performance in paediatric subjects in Indian population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RG/CRO/CIP (IFT), Version 3.0, Dated 01 June 2023. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Kala |
| Designation |
Principal & Dean |
| Affiliation |
GSVM Medical College |
| Address |
Ground Floor department of General Surgery Principal office GSVM Medical College Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8726555577 |
| Fax |
|
| Email |
dr_sanjay_kala@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Kumar |
| 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 |
8006599926 |
| Fax |
|
| Email |
singhalrohit10000@gmail.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 |
anoopbatra2014@gmail.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 Sanjay Kala |
G.S.V.M Medical College |
Ground Floor department of General Surgery Principal office GSVM Medical College Swaroop Nagar
Kanpur Nagar
UTTAR PRADESH |
8726555577
dr_sanjay_kala@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College |
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 |
| Intervention |
Infant Feeding Tube GS-4008 & Feedy GS-4038 Sizes FG-04,05,06,07,08,09,10.
|
Device maximum use duration is not more than 7 days. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1 Paediatrics male and female who are expected to require enteral nutrition feeding introduction of fluids etc. in paediatrics whose parents legal guardians are willing to provide written informed assent form will be eligible for inclusion in the follow-up.
2 Subjects parent LAR Legally Acceptable Representative can provide Informed Assent Form Child.
3 Parents or legal guardians must be able to complete all relevant follow-up procedures during follow-up participation. |
|
| ExclusionCriteria |
| Details |
1 Subject who present with medical emergency where treatment is more priority than the informed assent process.
2 Subjects paediatrics with severe malabsorption intestinal obstruction.
3 History of any reaction or hypersensitivity likely to be exacerbated by any components of the Infant Feeding Tube or Feedy.
4 Subject with congenital defect or serious chronic illness.
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 clinical investigation plan.
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 |
The Primary End Point of the study are as
1 Intubation of nasal or oral passage with Infant Feeding Tube clinically intended for enteral feeding purpose.
2 Facilitating clinical use for enteral feeding.
3 Facilitating clinical use for medical conditions requiring aspiration of gastric content.
4 Improving the quality of life of the subject by achieving the intended 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 Durability sustainability & device fixation with standard combination devices required the clinical use.
2 Device material compatibility with the body tissue & also with nutritional fluids or medications.
|
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)
|
04/03/2024 |
| 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 Infant Feeding Tube (Feedy) to explore safety and performance in paediatrics
that requires enteral nutrition feeding, introduction of fluids etc. 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 Assent Form will be obtained from all subjects and parents/legal
guardians. All data will be
collected in the follow-up specific Case Report Form. |