Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX, United Kingdom
Location status: Recruiting
Location contact
Consultant Urological Surgeon
CONTACT
+44 14 835 711 22 ext. 3392
Wissam Abou-Chedid
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07006090
EU Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Histolog Scanner
DeviceHistolog 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.
Primary outcomes
-
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)
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.
Sponsors and collaborators
Lead sponsor
SamanTree Medical SA
Industry
Registry information
Official study title
A Prospective, Observational, Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner in Multiple Disease Areas.
Acronym: EU - ORCHID
Important dates
- Study start
- 2026
- Primary completion
- 2036
- Study completion
- 2036
- First posted
- Jun 5, 2025
- Registry last updated
- Mar 5, 2026
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.