Status:
COMPLETED
A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma
Lead Sponsor:
NinePoint Medical
Conditions:
Barrett'S-associated Dysplasia
Intramucosal Adenocarcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly as...
Detailed Description
The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present, endoscopy with biopsy of suspected BE lesions is the only available method. However, the endoscopic recogniti...
Eligibility Criteria
Inclusion
- Males and females over the age of 18 years.
- Patients with either suspected or confirmed Barrett's-associated dysplasia or intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.
- \- Only en-bloc resections will be investigated, requiring lesions with a maximum diameter of 15 mm with a Paris classification of 0-IIa, b, c, or a combination.
- Ability to provide written, informed consent.
- Women of childbearing potential must be willing to take a pregnancy test.
Exclusion
- Patients on anticoagulation.
- Patients with esophageal varices that preclude either mucosal resection or biopsies.
- Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Catheter.
- Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE Catheter.
- Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Catheter.
- Patients with known eosinophilic esophagitis.
- Patients that are pregnant.
- Patients with a history of hemostasis disorders\*.
- Patients with esophagitis above grade A.
- Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01862666
Start Date
May 1 2013
End Date
January 1 2015
Last Update
June 19 2015
Active Locations (1)
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1
Academic Medical Center
Amsterdam, AZ, Netherlands, 1105