Recruiting
Phase 1
Phase 2

Tethered Capsule Endoscope

Sponsor:

US Department of Veterans Affairs

Code:

NCT00903136

Conditions

Esophageal Cancer

Precancerous Condition

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

questionnaire administration

comparison of screening methods

diagnostic endoscopic procedure

esophagogastroduodenoscopy

tethered capsule endoscopy

Study Details

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

Conditions

Esophageal Cancer

Precancerous Condition

Study ID

NCT00903136

Start date

May, 2009

Status verified date

Feb, 2010

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Primary purpose

Screening

Interventions and Outcome Measures

Interventions

questionnaire administration

comparison of screening methods

diagnostic endoscopic procedure

esophagogastroduodenoscopy

tethered capsule endoscopy

Primary outcome measure

  • Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I) [ Time Frame: undefined ]
  • Time required to image the squamo-columnar junction (Phase I) [ Time Frame: undefined ]
  • Number of repeated swallows to achieve esophageal imaging (Phase I) [ Time Frame: undefined ]
  • Amount of simethicone needed to reduce bubbles (Phase I) [ Time Frame: undefined ]
  • Need for effervescent granules or other approaches to distend the esophagus (Phase I) [ Time Frame: undefined ]
  • Time required for the entire TCE procedure (Phase I) [ Time Frame: undefined ]
  • Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I) [ Time Frame: undefined ]
  • Overall comfort during ingestion, pullback, and withdrawal of the TCE (Phase I) [ Time Frame: undefined ]
  • Sensitivity, specificity, and accuracy of the TCE for identifying suspected Barrett esophagus (Phase II) [ Time Frame: undefined ]
  • Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II) [ Time Frame: undefined ]
  • Time to perform the TCE exam (Phase II) [ Time Frame: undefined ]
  • Test characteristics of the first half vs the last half of the TCE exams performed by each of the 2 endoscopists (Phase II) [ Time Frame: undefined ]
  • Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II) [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Veterans Affairs Medical Center - Seattle

Recruiting

Seattle, Washington, United States, 98108

Contacts

Jason A. Dominitz, MD

206-764-2285

More Information

Sponsor

US Department of Veterans Affairs

Last update posted

Jan 10, 2014

Last verified

Feb, 2010

Keywords

  • Barrett esophagus
  • esophageal cancer
  • adenocarcinoma of the esophagus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by US Department of Veterans Affairs on 2014-01-10.