EU Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner.

NCT07006090 | Recruiting FDA Device

• 1 other identifier: ORCHID Histolog Registry - EU
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Whatever the Disease Area; Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner

Keywords

Histolog Scanner

Outcome Measures

Primary Outcomes (1)

• Number of confirmed medical interventions based on Histolog® image readings.

  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

  From enrolment to post surgery follow-up visit (V2: 37 days after enrolment)

• Re-operation rates if Histolog® used for intra-operative assessment

  From surgery (V1: Day 0) to post surgery follow-up visit (V2: +30 days)

• Cancer-free survival up to 5 years of follow-up

  From enrolment to the end of 5 years follow-up

• Evaluation of usage patterns across different indications and application profiles.

  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.

  From first patient surgery visit (V1: Day 0) to last patient surgery visit.

Study Arms (1)

Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner

unique cohort in the study

Device: Histolog Scanner

Interventions

Histolog Scanner DEVICE

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.

Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients undergoing a surgery or a medical procedure with use of Histolog Scanner.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SamanTree Medical SA: lead

Study Sites (1)

Royal Surrey County Hospital NHS Foundation Trust

Guildford, GU2 7XX, United Kingdom

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: March 4, 2026
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): April 1, 2036
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)