Spot Ex PMCF 01 Study
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Laborie Medical Technologies Inc.
- Study ID
- NCT07206615
- Status
- Enrolling By Invitation
Conditions
- Presence of Spot Ex Endoscopic Marker
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Endoscopic marker — OTHERStudy to confirm the safety and performance of the Laborie Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).
Study Details
Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker
Key Dates
- Start date
- Oct 31, 2025
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: Spot Ex Endoscopic MarkerSubjects with Spot Ex Endoscopic Marker present 36 months post-tattoo
Primary Outcome Measure
Longevity [ Time Frame: From endoscopic marker placement date to 36 months post-tattoo date ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| IU Health University Hospital | Indianapolis | Indiana | 46202 | - |
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