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 range

18 Years – 80 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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