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.
Not Applicable
Completed
- Conditions
- Health Condition 1: K20-K31- Diseases of esophagus, stomach and duodenum
- Registration Number
- CTRI/2024/02/063083
- Lead Sponsor
- Biotechnology Industry Research Assistance Council (BIRAC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Willingness to participate
- Clinical diagnosis of GI tract disorder
- Stable medical conditions
Exclusion Criteria
- Unwillingness to participate
- Patients with cardiovascular and uncontrolled diabetic condition
- Unstable medical condition
- Pregnant women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance Evaluation Metrics - Mechanical, Video Processor, Software & System Stability, Image Quality. <br/ ><br>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.Timepoint: 2 months
- Secondary Outcome Measures
Name Time Method To obtain feedback and preference about the mBLU modes implemented in the systemTimepoint: 2 months