Development And Implementation of a Vision Based Tele-Surgical Robotic System for Remote Wound Assessment: A Descriptive Study in a Tertiary Care Hospital in Mandya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This is a single arm interventional medical device and diagnostic feasibility study to evaluate a robotic depth camera based system for non contact wound assessment in a tertiary care hospital in Mandya, India. A teleoperated robotic arm carrying a close range three dimensional depth camera is used to capture colour and depth images of surface wounds without touching the patient. Machine learning based algorithms automatically estimate wound length, width and maximum depth and generate a three dimensional wound map. In each patient these automated measurements are compared with standard manual measurements made by the treating surgeon using a sterile measuring scale. The study plans to enroll about fifty patients aged ten years and above who present with surface wounds or minor soft tissue trauma and are clinically stable. Primary outcomes include diagnostic accuracy of the automated measurements. Secondary outcomes include the proportion of wounds within a predefined error range, time taken for assessment, image and segmentation quality, and usability and acceptability of the system among surgeons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 10.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged ten years and above with surface wounds or minor soft tissue trauma such as abrasions, lacerations, sutured wounds or postoperative surface wounds that can be safely exposed for imaging.
- •Patients must be haemodynamically stable at the time of assessment.
- •Written informed consent will be obtained from the patient or from a parent or legally authorised representative in case of minors, with assent from the child wherever appropriate.
排除标准
- •Life threatening trauma or deep internal injuries requiring immediate emergency surgery.
- •Wounds with heavy active bleeding, extensive necrosis or gross infection where imaging could delay treatment.
- •Large area burns or wounds where adequate exposure for imaging is not possible.
- •Known pregnant women are excluded because pregnancy is considered a vulnerable condition and this initial feasibility study does not specifically evaluate risks or benefits in pregnant patients.
- •Patients who are unable or unwilling to provide written informed consent are also excluded.
研究者
Dr N Lingaraju
Mandya Institute of Medical Science
