View Clinical Trial (Medical Research Study)
Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia - NCT01032044-(Clinical Trial 447290)
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Seattle |
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State:
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WA |
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| Conditions: |
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Barrett Syndrome - Barrett's Syndrome - Barrett's Esophagus - Barrett Esophagus - Adenocarcinoma |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 |
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| Study is available at: |
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University of Washington Medical Center Seattle, WA United States
Primary Contact: Michael Saunders, MD Email: michaels@medicine.washington.edu Phone: 206-221-6526 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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