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OpenTrials
Completed

NCT Number: NCT05783284

HS2 US Liver Reader Study

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).

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Key information

Conditions

Reader Study

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

No exclusion criteria

Treatment and study plan

Holocare Studio 2 (HS2)

Device

3D HV

Primary outcomes

  1. Identification of all pre-defined landmarks.

    Time frame: 3 days

    All readers able to identify all pre-defined landmarks.

Secondary outcomes

  1. 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).

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

HoloCare AS

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.