HS2 US Liver Reader Study

HoloCare

Status: Completed

Conditions: Reader Study

Treatments: Device: Holocare Studio 2 (HS2)

Study type: Observational

Funder types: Industry

Identifiers

NCT05783284

CIHS2-002

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

No exclusion criteria

Trial design

22 participants in 1 patient group

Readers

Description:

5 trained GI surgeons within liver surgery (the readers) will identify pre-defined anatomical landmarks in liver CT images that have been processed by HS2

Treatment:

Device: Holocare Studio 2 (HS2)