HS2 US Liver Reader Study

• Sponsor: HoloCare AS (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05783284
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Actual Duration (Days): 2
• Patients Per Site Per Month: 334.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Reader Study	Device: Holocare Studio 2 (HS2)

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 Design

• Study Type: Observational
• Actual Enrollment: 22 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: HS2 US Liver Reader Study
• Actual Study Start Date: Mar 2, 2023
• Actual Primary Completion Date: Mar 4, 2023
• Actual Study Completion Date: Mar 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Readers 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	Device: Holocare Studio 2 (HS2); 3D HV

Outcome Measures

Primary Outcome Measures

1. Identification of all pre-defined landmarks. [3 days]

   All readers able to identify all pre-defined landmarks.

Secondary Outcome Measures

1. 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).

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• HoloCare AS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HoloCare AS
• ClinicalTrials.gov Identifier: NCT05783284
• Other Study ID Numbers: CIHS2-002
• First Posted: Mar 24, 2023
• Last Update Posted: Mar 24, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by HoloCare AS: Holographic visualization

Study Results

No Results Posted as of Mar 24, 2023