Spot Ex PMCF 01 Study

Laborie Medical Technologies

Status: Invitation-only

Conditions: Presence of Spot Ex Endoscopic Marker

Treatments: Other: Endoscopic marker

Study type: Observational

Funder types: Industry

Identifiers

NCT07206615

CLN-00082

Details and patient eligibility

About

Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker

Full description

This study is a medical chart review to confirm the safety and performance of the Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.

Exclusion criteria

• 1. Patients who had the marked tissue resected less than 3 years after initial marking.
• 2. Inadequate medical documentation to ascertain visualization of the marking.
• 3. Inability to visualize or image the marking due to poor colonoscopy preparation.
• 4. Patients considered as Vulnerable Populations, as defined in CFR - Code of Federal Regulations Title 21

Trial design

60 participants in 1 patient group

Spot Ex Endoscopic Marker

Description:

Subjects with Spot Ex Endoscopic Marker present 36 months post-tattoo

Treatment:

Other: Endoscopic marker