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临床试验/NCT03670849
NCT03670849已完成不适用

Ultrasound Augmentation of Stereoscopic and Conventional Video for Laparoscopic Surgeries

Raj Shekhar2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
System set-up time

研究概览

简要总结

The objective of this study is to test the technical feasibility of LapAR visualization system for guiding laparoscopic surgeries and to gather clinical feedback on the use of this tool.

详细描述

Surgeons use real-time video generated by a laparoscope to visualize the operative field when performing laparoscopic procedures. An inability to see beneath organ surfaces is a limitation of the current visualization technology. Surgeons additionally use laparoscopic ultrasound to see beneath organ surfaces, but also need to mentally correlate the ultrasound image with the video of the operative field. This process is difficult, subjective, and variable with expertise, and discourages the use of ultrasound.

We have developed a method to combine live laparoscopic video and laparoscopic ultrasound images to present fused multimodality images on a single display, eliminating the need for mental image correlation. Specifically, the image fusion method, called laparoscopic augmented reality (LapAR), augments the laparoscopic video with ultrasound data when required by surgeons. For ablations, we further track the needle and overlay its path on the AR view for precise needle placement. This study is designed to test this minimal-risk capability in patients referred for relevant laparoscopic procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Year 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred for laparoscopic cholecystectomy or liver ablation
  • Clinical indication for the use of laparoscopic ultrasound
  • Patient or an authorized guardian provides written consent

排除标准

  • Patients with pacemaker or any other ICD (intra-cardiac device) which may interfere with electromagnetic tracking

结局指标

主要结局

System set-up time

时间窗: before surgery, an expected average of 15 min

Usability

时间窗: post surgery, an expected average of 5 minutes

The ease of use of the LapAR system will be evaluated by the surgeon

次要结局

未报告次要终点

研究者

发起方
Raj Shekhar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raj Shekhar

Principal Investigator

Children's National Research Institute

研究点 (2)

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