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临床试验/NCT05783284
NCT05783284已完成不适用

HS2 US Liver Reader Study

HoloCare AS1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年3月2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
HoloCare AS
入组人数
22
试验地点
1
主要终点
Identification of all pre-defined landmarks.

研究概览

简要总结

The purpose of this study is to to assess the ability of 5 Gastro-Intestinal (GI) surgeons, within liver surgery, the readers, to identify pre-defined anatomical landmarks in liver images processed by HS2, and assessment of landmark distance between CT and Holographic visualization (HV).

详细描述

This is a retrospective investigation of Computer Topographies (CTs)/ Holographic visualization based on CTs retrieved from patients with metastases in the liver from colorectal cancer.

The study consists of:

  • Preparations at Day 0. The reader is not involved in the preparation
  • Using of HS2 and evaluation at Day 1-2
  • Calculation at Day 3.

The study will enroll eligible subject's images.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Livers with colorectal cancer liver metastasis
  • CTs from individuals 22 years or older
  • CTs retrieved from US hospitals
  • CTs from patients treated in the US
  • At least 1 visible liver lesion to complete detection of L1

排除标准

  • No exclusion criteria

结局指标

主要结局

Identification of all pre-defined landmarks.

时间窗: 3 days

All readers able to identify all pre-defined landmarks.

次要结局

  • Evaluate ease of use.(3 days)
  • Comparison between CT and HV distance.(3 days)
  • Comparison of image quality between CT and HV.(3 days)

研究者

发起方
HoloCare AS
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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