Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

Trial Title: Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

NCT ID: NCT00903136

Condition: Esophageal Cancer
Precancerous Condition

Conditions: Official terms:
Esophageal Neoplasms
Barrett Esophagus
Precancerous Conditions

Conditions: Keywords:
Barrett esophagus
esophageal cancer
adenocarcinoma of the esophagus

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Unknown status

Study design:

Primary purpose: Screening

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: questionnaire administration

Intervention type: Procedure
Intervention name: comparison of screening methods

Intervention type: Procedure
Intervention name: diagnostic endoscopic procedure

Intervention type: Procedure
Intervention name: esophagogastroduodenoscopy

Intervention type: Procedure
Intervention name: tethered capsule endoscopy

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 The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is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

Criteria for eligibility:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Veterans Affairs Medical Center - Seattle

Address:
City: Seattle
Zip: 98108
Country: United States

Status: Recruiting

Contact:
Last name: Jason A. Dominitz, MD

Phone: 206-764-2285

Start date: May 2009

Lead sponsor:
Agency: US Department of Veterans Affairs
Agency class: U.S. Fed

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00903136