| CTRI Number |
CTRI/2024/02/063083 [Registered on: 23/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Validating if an endoscopy system made in India is safe and works well when doctors use it to look inside a persons stomach during a gastroscopy procedure. |
|
Scientific Title of Study
|
Clinical Validation of Smart EYE Endoscopy System |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkateswaran G |
| Designation |
Head, Department of Surgery |
| Affiliation |
Sri Venkateswaraa Medical College Hospital and Research Institute |
| Address |
Room 2102, Surgery OPD, First Floor, Sri Venkateswaraa Medcity
Nallur Toll Plaza, 51, GNT Rd, Red Hills, Padianallur, Siruniam
Thiruvallur
TAMIL NADU
600067
India |
| Phone |
|
| Fax |
|
| Email |
gopalvenkat1959@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amalan S |
| Designation |
Lead ISP Engineer |
| Affiliation |
Healthcare Technology Innovation Centre |
| Address |
Endoscopy R&D Division, No 1, 5th floor, C Block, IIT Madras Research Park, Kanagam Road, Tharamani
Chennai
TAMIL NADU
600113
India |
| Phone |
9884111661 |
| Fax |
|
| Email |
amalan@htic.iitm.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Amalan S |
| Designation |
Lead ISP Engineer |
| Affiliation |
Healthcare Technology Innovation Centre |
| Address |
Endoscopy R&D Division, No 1, 5th floor, C Block, IIT Madras Research Park, Kanagam Road, Tharamani
TAMIL NADU
600113
India |
| Phone |
9884111661 |
| Fax |
|
| Email |
amalan@htic.iitm.ac.in |
|
|
Source of Monetary or Material Support
|
| Biotechnology Industry Research Assistance Council (BIRAC) |
|
|
Primary Sponsor
|
| Name |
Biotechnology Industry Research Assistance Council (BIRAC) |
| Address |
5th Floor, NSIC Business Park, NSIC Bhawan,
Okhla Industrial Estate, New Delhi - 110020 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mitra Medical Services LLP |
B-226, Okhla Industrial Area,
Phase 1, New Delhi 110020, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Venkateswaran G |
Sri Venkateswaraa Medical College Hospital and Research Institute |
Room 2102, Surgery OPD, First Floor, Sri Venkateswaraa Medcity, Nallur Toll Plaza, 51, GNT Rd, Red Hills, Padianallur, Siruniam, Tamil Nadu 600067
Thiruvallur
TAMIL NADU |
8939135061
gopalvenkat1959@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswaraa Medcity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
Observational Trial |
| Intervention |
NIL |
Observational Trial - Clinically Validating an Endoscopy system by performing usual Gastroscopy procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Willingness to participate
- Clinical diagnosis of GI tract disorder
- Stable medical conditions |
|
| ExclusionCriteria |
| Details |
- Unwillingness to participate
- Patients with cardiovascular and uncontrolled diabetic condition
- Unstable medical condition
- Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Performance Evaluation Metrics - Mechanical, Video Processor, Software & System Stability, Image Quality.
For each of the 4 performance metrics, the gastroenterologist will be asked to give a score out of 5, with 5 being the highest. Average of the performance metrics for each category will be computed and used for decision making. An average of above 3.5 out of 5 will be considered as PASS. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obtain feedback and preference about the mBLU modes implemented in the system |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
01/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
SmartEYE Ultra is an endoscopy system indigenously designed and developed by Healthcare Technology Innovation Center (HTIC), Indian Institute of Technology (IIT), Madras for Mitra Medical Services LLP, Parwanoo under the National Biopharma Mission (NBM - an Industry-Academia Collaborative Mission of Department of Biotechnology (DBT)) implemented by BIRAC (Biotechnology Research Assistance Council). The endoscopy system has been certified for EMI/EMC compliance by SAMEER CEM, Chennai. The device has also been certified for basic safety compliance under IEC 60601-1 by ITC India Pvt. Ltd., Chandigarh. The device was also taken for Animal Trials at the Palamur Biosciences Pvt. Ltd., Mahabubnagar, Telangana, which issued a report clearing the SE Ultra system for use in gastroscopic evaluations of human subjects in clinical setups.
SmartEYE Ultra endoscopy system needs to be evaluated for its performance in mechanical handling, video processing, software system stability and image quality. For this, the SmartEYE Ultra system will be used in endoscopic procedures on 30 human subjects, during which the gastroenterologists will be asked to evaluate the above metrics based on the proforma for evaluation. The evaluation reports from the gastroenterologists will be used as a proof for clinical trials on humans and based on these reports the SE Ultra system is expected to be cleared for clinical use in hospitals. |