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Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

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ClinicalTrials.gov Identifier: NCT00903136
Recruitment Status : Unknown
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 18, 2009
Last Update Posted : January 10, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE May 15, 2009
First Posted Date  ICMJE May 18, 2009
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2009)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00903136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2009)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
Official Title  ICMJE Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Esophageal Cancer
  • Precancerous Condition
Intervention  ICMJE
  • Other: questionnaire administration
  • Procedure: comparison of screening methods
  • Procedure: diagnostic endoscopic procedure
  • Procedure: esophagogastroduodenoscopy
  • Procedure: tethered capsule endoscopy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 15, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00903136
Other Study ID Numbers  ICMJE CDR0000641937
VAMC-WA-33141
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jason A. Dominitz, Veterans Affairs Medical Center - Seattle
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Jason A. Dominitz, MD VA Puget Sound Health Care System
PRS Account National Cancer Institute (NCI)
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP