Enrolling by invitation NCT07206615
Spot Ex PMCF 01 Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic marker.
- Who it may be relevant to
- Registry conditions: Presence of Spot Ex Endoscopic Marker. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post Market Clinical Follow-Up Study - Chart Review of the Spot Ex Endoscopic Marker
Overview
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).
Interventions
- Other Endoscopic 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).
Primary outcome measures
- Longevity [Time frame: From endoscopic marker placement date to 36 months post-tattoo date]
Secondary outcome measures (1)
- Safety Endpoint [Time frame: From endoscopic marker placement date to 36 months post-tattoo date]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- IU Health University Hospital — Indianapolis
Identifiers
NCT: NCT07206615 · CLN-00082