Presence of Spot Ex Endoscopic Marker
Conditions
Keywords
Spot Ex, Endoscopic Marker, Laborie
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).
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).
Sponsors
Laborie Medical Technologies Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Longevity | From endoscopic marker placement date to 36 months post-tattoo date | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint | From endoscopic marker placement date to 36 months post-tattoo date | Percent of treatment-related adverse events specified in the protocol. |
Countries
United States
Outcome results
None listed