Status:
ENROLLING_BY_INVITATION
Spot Ex PMCF 01 Study
Lead Sponsor:
Laborie Medical Technologies Inc.
Conditions:
Presence of Spot Ex Endoscopic Marker
Eligibility:
All Genders
18+ years
Brief Summary
Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker
Detailed 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).
Eligibility Criteria
Inclusion
- Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07206615
Start Date
October 1 2025
End Date
December 1 2025
Last Update
October 14 2025
Active Locations (1)
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1
IU Health University Hospital
Indianapolis, Indiana, United States, 46202