NCT07206615

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 14, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 26, 2025

Last Update Submit

October 9, 2025

Conditions

Presence of Spot Ex Endoscopic Marker

Keywords

Spot ExEndoscopic MarkerLaborie

Outcome Measures

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.

    From endoscopic marker placement date to 36 months post-tattoo date

Secondary Outcomes (1)

  • Safety Endpoint

    From endoscopic marker placement date to 36 months post-tattoo date

Study Arms (1)

Spot Ex Endoscopic Marker

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

Other: Endoscopic marker

Interventions

Endoscopic markerOTHER

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

Spot Ex Endoscopic Marker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.

You may not qualify if:

  • \. Patients who had the marked tissue resected less than 3 years after initial marking.
  • \. Inadequate medical documentation to ascertain visualization of the marking.
  • \. Inability to visualize or image the marking due to poor colonoscopy preparation.
  • \. Patients considered as Vulnerable Populations, as defined in CFR - Code of Federal Regulations Title 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2025

First Posted

October 3, 2025

Study Start

October 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 14, 2025

Record last verified: 2025-09

Locations

US(1)