UnknownPhase 1/2

Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

United States50 participantsStarted 2009-05

Plain-language 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 studying how well a tethered capsule endoscope works in screening participants for Barrett esophagus.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)

Time required to image the squamo-columnar junction (Phase I)

Number of repeated swallows to achieve esophageal imaging (Phase I)

Amount of simethicone needed to reduce bubbles (Phase I)

Need for effervescent granules or other approaches to distend the esophagus (Phase I)

Time required for the entire TCE procedure (Phase I)

Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I)

Overall comfort during ingestion, pullback, and withdrawal of the TCE (Phase I)

Sensitivity, specificity, and accuracy of the TCE for identifying suspected Barrett esophagus (Phase II)

Trial details

NCT IDNCT00903136

SponsorUS Department of Veterans Affairs

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2011-12

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