Spot Ex PMCF 01 Study | NCT07206615

Studies
Spot Ex PMCF 01 Study

NCT07206615

Sponsor

Laborie Medical Technologies Inc.

Status

Enrolling by invitation

Last Update Posted

Oct 14, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Presence of Spot Ex Endoscopic Marker

Interventions

Endoscopic marker

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2025Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 26, 2025

First Submission Date that Met QC Criteria

Sep 26, 2025

First Posted Date

Oct 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2025

Last Update Posted Date

Oct 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spot Ex Endoscopic Marker		Subjects with Spot Ex Endoscopic Marker present 36 months post-tattoo	Other: Endoscopic marker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic marker	Other	Study to confirm the safety and performance of the Laborie Spot Ex Endoscopic Marker in accordance with the approved labelling/instructions for use (IFU).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Safety Endpoint	Percent of treatment-related adverse events specified in the protocol.	From endoscopic marker placement date to 36 months post-tattoo date

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IU Health University Hospital		Indianapolis	Indiana	46202	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided