HS2 US Liver Reader Study

March 13, 2023 updated by: HoloCare AS
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

US patients whose liver CT images will be used to create HVs.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of all pre-defined landmarks.
Time Frame: 3 days
All readers able to identify all pre-defined landmarks.
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between CT and HV distance.
Time Frame: 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).
3 days
Comparison of image quality between CT and HV.
Time Frame: 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 days
Evaluate ease of use.
Time Frame: 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.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HoloCare AS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Actual)

March 4, 2023

Study Completion (Actual)

March 4, 2023

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIHS2-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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