Feasibility study with the VLE Laser marking system
Recruiting
- Conditions
- Barrett's esophagus, early adenocarcinoma
- Registration Number
- NL-OMON19997
- Lead Sponsor
- AMC Medical Research
- Brief Summary
none yet
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 17
Inclusion Criteria
•Patients over the age of 18
•Patients undergoing an upper endoscopy for BE surveillance with prior confirmed BE, with or without neoplasia.
Exclusion Criteria
•Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe.
•Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Optical Probe.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this trial is to determine the visibility and positional accuracy of laser marks applied by the NvisionVLE Imaging System. <br /><br /><br><br>Primary outcome measures<br /><br>•Percentage of laser marks visible to the physician using WLE and VLE<br /><br>•Positional accuracy of laser marks <br>
- Secondary Outcome Measures
Name Time Method •All adverse events will be collected and analyzed.<br>