Health Condition 1: K20-K31- Diseases of esophagus, stomach and duodenum
Conditions
Interventions
Intervention1: NIL: Observational Trial - Clinically Validating an Endoscopy system by performing usual Gastroscopy procedures
Control Intervention1: NIL: Observational Trial
Sponsors
Biotechnology Industry Research Assistance Council (BIRAC)
Mitra Medical Services LLP
Eligibility
Inclusion criteria
Inclusion criteria: - Willingness to participate - Clinical diagnosis of GI tract disorder - Stable medical conditions
Exclusion criteria
Exclusion criteria: - Unwillingness to participate - Patients with cardiovascular and uncontrolled diabetic condition - Unstable medical condition - Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To obtain feedback and preference about the mBLU modes implemented in the systemTimepoint: 2 months | — |
Countries
India
Contacts
Public ContactAmalan S
Healthcare Technology Innovation Centre
Outcome results
None listed