Clinical Validation of Smart EYE Endoscopy System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Performance Evaluation Metrics - Mechanical, Video Processor, Software & System Stability, Image Quality.
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Performance Evaluation Metrics - Mechanical, Video Processor, Software & System Stability, Image Quality.
Time Frame: 2 months
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.
Time Frame: 2 months
Secondary Outcomes
- To obtain feedback and preference about the mBLU modes implemented in the system(2 months)
Investigators
Dr Venkateswaran G
Sri Venkateswaraa Medical College Hospital and Research Institute