EU Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Histolog Scanner.
- Who it may be relevant to
- Registry conditions: Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner, Whatever the Disease Area. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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.
Interventions
- Device Histolog Scanner
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.
Primary outcome measures
- 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 outcome measures (5)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Royal Surrey County Hospital NHS Foundation Trust — Guildford
Identifiers
NCT: NCT07006090 · ORCHID Histolog Registry - EU