Reader Study
Conditions
Keywords
Holographic visualization
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.
Interventions
DEVICEHolocare Studio 2 (HS2)
3D HV
Sponsors
HoloCare AS
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of all pre-defined landmarks. | 3 days | All readers able to identify all pre-defined landmarks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed