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NCT07206615

Spot Ex PMCF 01 Study

Enrolling by Invitation
Not specifiedAges 18+Observational
Laborie Medical Technologies Inc.
~60 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:Endoscopic marker

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Longevity
Measured over From endoscopic marker placement date to 36 months post-tattoo date

Conditions

Presence of Spot Ex Endoscopic Marker

Explore related trials

Digestive System Disorder

Where it's being run

1 sites across 1 states
Indiana1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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

What this trial measures

  • LongevityFrom endoscopic marker placement date to 36 months post-tattoo date

    Visual confirmation at 36 months - Percent of subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months.