Status:
UNKNOWN
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Precancerous Condition
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of the esophagus, stomach, and duodenum in screening for Barrett esophagus. PURPOSE: This phase I/II trial is...
Detailed Description
OBJECTIVES: * To determine the clinical feasibility of obtaining endoscopic esophageal images using a tethered capsule endoscope (TCE). (Phase I) * To determine the optimal weight and possibly shape ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meets one of the following criteria:
- Healthy participant (phase I)
- Scheduled to undergo esophagogastroduodenoscopy at the VA Puget Sound Health Care System for the evaluation of reflux symptoms (including screening for Barrett esophagus \[BE\]) or for follow-up of known BE (phase II)
- No current diagnosis of cancer
- PATIENT CHARACTERISTICS:
- Not pregnant
- Able to fast for ≥ 6 hours prior to scheduled appointment
- No symptoms of dysphagia
- No history of a swallowing disorder (e.g., scleroderma, achalasia, esophageal stricture, or esophageal diverticulum)
- No history of a known or suspected gastrointestinal (GI) obstruction
- No other major medical illnesses (e.g., unstable cardiovascular disease, end-stage liver or kidney disease, or suspected active GI bleeding)
- No major physical disability that would prevent the participant from transferring from a chair to a bed and sitting up
- Not planning to undergo an MRI within 2 weeks after the study procedure
- PRIOR CONCURRENT THERAPY:
- No prior surgery on the oropharynx, neck, esophagus, or stomach
- No concurrent anticoagulant medications or clopidogrel
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00903136
Start Date
May 1 2009
Last Update
January 10 2014
Active Locations (1)
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1
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108