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CompletedNCT07206615Spot Ex PMCFUpdated Aug 25, 2026

Spot Ex PMCF 01 Study

An observational study in Presence of Spot Ex Endoscopic Marker, sponsored by Laborie Medical Technologies Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Laborie Medical Technologies Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Presence of Spot Ex Endoscopic Marker

Keywords

  • Spot Ex
  • Endoscopic Marker
  • Laborie
03

In context

Lead sponsor

Laborie Medical Technologies Inc. is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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).

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Spot Ex Endoscopic Marker

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

    Other: Endoscopic marker

Interventions

  • OtherEndoscopic marker

    Study to confirm the safety and performance of the Laborie Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).

06

What researchers measure

Primary outcomes

  1. Longevity

    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.

    Time frame: From endoscopic marker placement date to 36 months post-tattoo date

Secondary outcomes

  1. Safety Endpoint

    Percent of treatment-related adverse events specified in the protocol.

    Time frame: From endoscopic marker placement date to 36 months post-tattoo date

07

Study locations

1 site
  • IU Health University Hospital
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07206615
Lead sponsor
Laborie Medical Technologies Inc.
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Oct 1, 2025
Primary completion
Aug 21, 2026
Completion
Aug 21, 2026
Last update
Aug 25, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Laborie Medical Technologies Inc.

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