EU registry of real-world use of the Histolog® Scanner during surgeries and medical procedures
A Prospective, Observational, Post-Market Registry to Collect Real-World Clinical Data on the Use of the Histolog Scanner in Multiple Disease Areas.
This project will collect real-world data to see how the Histolog® Scanner works and how safe it is for adults who have tissue imaged during surgery or other medical procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SamanTree Medical SA Industry-sponsored |
| Locations | 1 site (Guildford) |
| Trial ID | NCT07006090 on ClinicalTrials.gov |
What this trial studies
The registry will prospectively collect observational, post-market clinical data on the Histolog® Scanner, a real-time ex‑vivo tissue imaging device, when used as intended during surgeries and medical procedures. Adult patients (≥18) who undergo a procedure with the device and provide informed consent will be enrolled at participating centres. Data captured will include device performance metrics, safety events, and clinical context without changing standard patient care. Patients in concurrent interventional trials or under legal guardianship are excluded.
Who should consider this trial
Good fit: Adults aged 18 and older undergoing a surgery or procedure where the Histolog® Scanner is used, who can give informed consent and are not enrolled in an ongoing interventional study, are ideal candidates.
Not a fit: Children, patients whose procedures do not use the Histolog® Scanner, those unable to consent, or those enrolled in another ongoing interventional study are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the registry could provide real-world safety and performance evidence that helps clinicians use the device more confidently and may support regulatory and reimbursement decisions.
How similar studies have performed: Similar ex‑vivo, real‑time tissue imaging technologies have shown feasibility in pilot studies, but broad post‑market evidence specifically for the Histolog® Scanner remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guildford
- Royal Surrey County Hospital NHS Foundation Trust — Guildford, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.