Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

NCT ID: NCT00903136

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31

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 The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is reached.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.

Conditions

Esophageal Cancer; Precancerous Condition

Study Design

• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

questionnaire administration

Intervention Type: OTHER

comparison of screening methods

Intervention Type: PROCEDURE

diagnostic endoscopic procedure

Intervention Type: PROCEDURE

esophagogastroduodenoscopy

Intervention Type: PROCEDURE

tethered capsule endoscopy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Veterans Affairs Medical Center - Seattle

Principal Investigators

Jason A. Dominitz, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

Veterans Affairs Medical Center - Seattle

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jason A. Dominitz, MD

Role: primary

206-764-2285

Other Identifiers

VAMC-WA-33141

Identifier Type: -

Identifier Source: secondary_id

CDR0000641937

Identifier Type: -

Identifier Source: org_study_id