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

SamanTree Medical SA5,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Royal Surrey County Hospital NHS Foundation Trust

Guildford, United Kingdom

RECRUITING

Outcomes

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.

Data from ClinicalTrials.gov

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