Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

January 9, 2014 updated by: US Department of Veterans Affairs

Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 for rapid patient ingestion and extraction of the TCE. (Phase I)
  • To determine the optimal tether design (e.g., rigidity, distance markings, and other material properties). (Phase I)
  • To determine the optimal protocol for patient ingestion and extraction of the TCE. (Phase I)
  • To compare the TCE to standard sedated esophagogastroduodenoscopy for identifying suspected Barrett esophagus. (Phase II)

OUTLINE:

  • Phase I: Participants swallow the tethered capsule endoscope (TCE) so that the distal end of the TCE enters the stomach. The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is reached. The image acquisition process is repeated and the participant may be asked to swallow the TCE in up to 7 different positions with 2 swallows per position (no more than 20 swallows total).
  • Phase II: Participants undergo TCE as in phase I, followed by standard sedated esophagogastroduodenoscopy (EGD) by a second physician.

Images obtained via TCE and EGD are reviewed by a third physician blinded to the results of each exam.

In both phases, participants and physicians complete a questionnaire after the TCE procedure to determine the ease of the procedure. Participants are also asked for specific suggestions to improve the TCE experience. Participants enrolled in phase II also complete a questionnaire 1 week after EGD to compare the TCE procedure with the EGD.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • Recruiting
        • Veterans Affairs Medical Center - Seattle
        • Contact:
          • Jason A. Dominitz, MD
          • Phone Number: 206-764-2285

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II)
Time to perform the TCE exam (Phase II)
Test characteristics of the first half vs the last half of the TCE exams performed by each of the 2 endoscopists (Phase II)
Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II)

Secondary Outcome Measures

Outcome Measure
Ability of the TCE to identify the presence or absence of other esophageal lesions (e.g., inflammation, diverticula, or varices) (Phase II)
Results of the histologic analysis of any biopsy specimens (Phase II)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jason A. Dominitz, MD, VA Puget Sound Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000641937
  • VAMC-WA-33141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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