Clinical Validation of Smart EYE Endoscopy System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Performance Evaluation Metrics - Mechanical, Video Processor, Software & System Stability, Image Quality.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Willingness to participate.
- •Clinical diagnosis of GI tract disorder.
- •Stable medical conditions.
排除标准
- •Unwillingness to participate.
- •Patients with cardiovascular and uncontrolled diabetic condition.
- •Unstable medical condition.
- •Pregnant women.
结局指标
主要结局
Performance Evaluation Metrics - Mechanical, Video Processor, Software & System Stability, Image Quality.
时间窗: 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.
时间窗: 2 months
次要结局
- To obtain feedback and preference about the mBLU modes implemented in the system(2 months)
研究者
Dr Venkateswaran G
Sri Venkateswaraa Medical College Hospital and Research Institute