Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® ScannerEU - ORCHIDNCT07006090
EU Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner.
An observational study of Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner and Whatever the Disease Area, run by SamanTree Medical SA at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to gather real-world evidence on the performance and safety of the Histolog® Scanner (HLS) when used as intended. HLS is a real-time ex-vivo tissue imaging device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner, Whatever the Disease Area
- What is being tested?
- Histolog Scanner
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2026to Apr 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients undergoing a surgery or a medical procedure with use of Histolog Scanner.
Who may be able to join
- Age ≥18 years old at the time of consenting
- Undergoing a surgery or a medical procedure with use of Histolog® Scanner
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Active participation in a drug, device, or other medical intervention study that has not reached its primary endpoint at the time of consenting
- Patients under judicial protection, legal guardianship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX
Consultant Urological Surgeon, +44 14 835 711 22 ext. 3392, w.abouchedid@nhs.net
Wissam Abou-Chedid
About this study
Official title: A Prospective, Observational, Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner in Multiple Disease Areas.
The goal of this observational study is to gather real-world evidence on the performance and safety of the Histolog® Scanner (HLS) when used as intended. HLS is a real-time ex-vivo tissue imaging device.
- Conditions
- Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner, Whatever the Disease Area
- Being tested
- Histolog Scanner
- Keywords
- Histolog Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Histolog ScannerDevice
Histolog Scanner intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner | unique cohort in the study Receives: Device: Histolog Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of confirmed medical interventions based on Histolog® image readings.
Measured: From enrolment to diagnosis confirmation at post surgery follow-up visit (V2: 37 days after enrolment)
Secondary outcomes (5)
Concordance between the assessment of Histolog® images and the final pathology assessment expressed as sensitivity, specificity, positive predictive value, and negative predictive value
Measured: From enrolment to post surgery follow-up visit (V2: 37 days after enrolment)
Re-operation rates if Histolog® used for intra-operative assessment
Measured: From surgery (V1: Day 0) to post surgery follow-up visit (V2: +30 days)
Cancer-free survival up to 5 years of follow-up
Measured: From enrolment to the end of 5 years follow-up
Evaluation of usage patterns across different indications and application profiles.
Measured: From enrolment to the end of 5 years follow-up.
Device deficiency defined as any inadequacy in the identity, quality, durability, reliability, safety or performance of a device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.
Measured: From first patient surgery visit (V1: Day 0) to last patient surgery visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start4 Mar 2026
- Primary completionMar 2036 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® ScannerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SamanTree Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006090
- Sponsor's protocol ID
- ORCHID Histolog Registry - EU
- Acronym
- EU - ORCHID
- Status last verified
- Mar 2026
- First submitted
- 27 May 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner in Multiple Disease Areas.
- ClinicalTrials.gov ID
- NCT07006090
- Acronym / sponsor ID
- EU - ORCHID / ORCHID Histolog Registry - EU
- Conditions
- Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner, Whatever the Disease Area
- Keywords
- Histolog Scanner
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- SamanTree Medical SAIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Mar 2036 (estimated)
- Study completion
- Apr 2036 (estimated)
- First posted
- 5 Jun 2025 (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 goal of this observational study is to gather real-world evidence on the performance and safety of the Histolog® Scanner (HLS) when used as intended. HLS is a real-time ex-vivo tissue imaging device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner | – | Device: Histolog Scannerunique cohort in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients undergoing a surgery or a medical procedure with use of Histolog Scanner.
Key inclusion criteria (3 listed)
- Age ≥18 years old at the time of consenting
- Undergoing a surgery or a medical procedure with use of Histolog® Scanner
- Ability to understand and the willingness to sign a written informed consent.
Key exclusion criteria (2 listed)
- Active participation in a drug, device, or other medical intervention study that has not reached its primary endpoint at the time of consenting
- Patients under judicial protection, legal guardianship or curatorship.
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 |
|---|---|---|
| Histolog ScannerHistolog Scanner intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture. | Device | Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner |
Primary outcome
Number of confirmed medical interventions based on Histolog® image readings.
Time frame: From enrolment to diagnosis confirmation at post surgery follow-up visit (V2: 37 days after enrolment)
5 secondary outcomes
Concordance between the assessment of Histolog® images and the final pathology assessment expressed as sensitivity, specificity, positive predictive value, and negative predictive value
Time frame: From enrolment to post surgery follow-up visit (V2: 37 days after enrolment)
Re-operation rates if Histolog® used for intra-operative assessment
Time frame: From surgery (V1: Day 0) to post surgery follow-up visit (V2: +30 days)
Cancer-free survival up to 5 years of follow-up
Time frame: From enrolment to the end of 5 years follow-up
Evaluation of usage patterns across different indications and application profiles.
Time frame: From enrolment to the end of 5 years follow-up.
Device deficiency defined as any inadequacy in the identity, quality, durability, reliability, safety or performance of a device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.
Time frame: From first patient surgery visit (V1: Day 0) to last patient surgery visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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.
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
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 Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner and Whatever the Disease Area, run by SamanTree Medical SA at 1 site in United Kingdom.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of confirmed medical interventions based on Histolog® image readings. (time frame: From enrolment to diagnosis confirmation at post surgery follow-up visit (V2: 37 days after enrolment)). 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 5 Mar 2026.