Spot Ex PMCF 01 Study

N/ACompletedNCT07206615

Laborie Medical Technologies Inc.60 enrolled

Overview

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

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Presence of Spot Ex 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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IU Health University Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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