CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Completed · Not applicable
Conditions studied: Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma
In brief
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE). It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.
Key facts
- Study ID
- NCT01032044
- Run by
- Mauna Kea Technologies
- People needed
- 164
- Starts
- 2010-02-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2016-04-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
- Undergoing any type of endoscopic BE ablation treatment
- <2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
- Age > 18 years
- Ability to provide written, informed consent
You may not qualify if…
- Participation in another clinical study
- Circumferential BE
- Complete eradication of BE documented by biopsies
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein
- Pregnancy
- Renal insufficiency
Where it is running
- Mayo Clinic — Jacksonville, Florida, United States
- University of Chicago Hospital — Chicago, Illinois, United States
- Veterans Affairs Hospital — Kansas City, Missouri, United States
- University of Washington Medical Center — Seattle, Washington, United States
- Centre Hospitalier Universitaire — Nantes, France
- University College London Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
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