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Colon marker study tracks visibility over 3 years

NCT ID NCT07206615

Knowledge-focused Sponsor: Laborie Medical Technologies Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study looks back at medical records of 60 people who had a Spot Ex marker placed in their colon to help doctors find spots during future exams. The main goal is to see if the marker is still visible after 3 years. Researchers also check for any side effects. This is an observational study, not a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Oct 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

60 subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months. Additional subjects may be screened to reach the minimum sample size required (60 subjects).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Presence of spot ex endoscopic marker

Contacts and locations

Locations

  • IU Health University Hospital

    Indianapolis, Indiana, 46202, United States