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

SamanTree Medical

Status: Not yet enrolling

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

Treatments: Device: Histolog Scanner

Study type: Observational

Funder types: Industry

Identifiers

NCT07006090

ORCHID Histolog Registry - EU

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,000 participants in 1 patient group

Adult patients undergoing a surgery or a medical procedure with use of Histolog® Scanner

Description:

unique cohort in the study

Treatment:

Device: Histolog Scanner