HS2 US Liver Reader Study

Completed

• Conditions: Reader Study
• Interventions: Device: Holocare Studio 2 (HS2)

• Registration Number: NCT05783284
• Lead Sponsor: HoloCare AS

Brief Summary

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).

Detailed 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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-02
• Primary Completion: 2023-03-04
• Study Completion: 2023-03-04
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Readers	Holocare Studio 2 (HS2)	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

Primary Outcome Measures

Name	Time	Method
Identification of all pre-defined landmarks.	3 days	All readers able to identify all pre-defined landmarks.

Secondary Outcome Measures

Name	Time	Method
Evaluate ease of use.	3 days	Evaluate ease of use on a 5-graded scale (1=very difficult, 2=difficult, 3=neither difficult nor easy, 4=easy, 5=very easy). All five readers scoring 4 or 5.
Comparison between CT and HV distance.	3 days	Comparison between CT and HV distance in mm between a marker in a defined center of each portal landmark (difference less than 8.0 mm).
Comparison of image quality between CT and HV.	3 days	Comparison of image quality between CT and HV on a 5-graded scale (1=HV significantly poorer quality than CT, 2=HV somewhat poorer quality than CT, 3=HV as good as CT, 4=HV somewhat better than CT, 5=HV significantly better than CT). More than 50% should be scored as HV as good as CT or better. All five readers scoring 3 or higher.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States