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

Not yet recruiting

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

• Registration Number: NCT07006090
• Lead Sponsor: SamanTree Medical SA

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 intraoperative tissue imaging device for assessment of surgical margins.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-27
• Study First Posted: 2025-06-05
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Study Start: 2025-11
• Primary Completion: 2033-11
• Study Completion: 2033-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.