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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner | unique cohort in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of adult patients undergoing a surgery or a medical procedure with use of Histolog Scanner.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey County Hospital NHS Foundation Trust | Recruiting | Guildford | GU2 7XX | United Kingdom |
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| 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. |