Reader StudyNCT05783284
HS2 US Liver Reader Study
An observational study of Reader Study, run by HoloCare AS at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Reader Study
- What is being tested?
- Holocare Studio 2 (HS2)
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2023to 4 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: US patients whose liver CT images will be used to create HVs.
Who may be able to join
- 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
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this 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).
Read the 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.
- Conditions
- Reader Study
- Being tested
- Holocare Studio 2 (HS2)
- Keywords
- Holographic visualization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holocare Studio 2 (HS2)Device
3D HV
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Holocare Studio 2 (HS2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of all pre-defined landmarks.
All readers able to identify all pre-defined landmarks.
Measured: 3 days
Secondary outcomes (3)
Comparison between CT and HV distance.
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).
Measured: 3 days
Comparison of image quality between CT and HV.
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.
Measured: 3 days
Evaluate ease of use.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start2 Mar 2023
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reader StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- HoloCare AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783284
- Sponsor's protocol ID
- CIHS2-002
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HS2 US Liver Reader Study
- ClinicalTrials.gov ID
- NCT05783284
- Acronym / sponsor ID
- CIHS2-002
- Conditions
- Reader Study
- Keywords
- Holographic visualization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- HoloCare ASIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Readers | – | Device: 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 |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- US patients whose liver CT images will be used to create HVs.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holocare Studio 2 (HS2)3D HV | Device | Readers |
Primary outcome
Identification of all pre-defined landmarks.
Time frame: 3 days
All readers able to identify all pre-defined landmarks.
3 secondary outcomes
Comparison between CT and HV distance.
Time frame: 3 days
Comparison of image quality between CT and HV.
Time frame: 3 days
Evaluate ease of use.
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reader Study, run by HoloCare AS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of all pre-defined landmarks. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.