Spot Ex PMCF 01 Study

Post Market Clinical Follow-Up Study - Chart Review of the Spot Ex Endoscopic Marker

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).

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