Adult Patients Undergoing a Surgery or a Medical Procedure With Use of Histolog® Scanner, Whatever the Disease Area
Conditions
Keywords
Histolog Scanner
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.
Interventions
DEVICEHistolog 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.
Sponsors
SamanTree Medical SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
| 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) |
| 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. |
Countries
United Kingdom
Outcome results
None listed