NCT00903136

Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is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

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	comparison of screening methods
PROCEDURE	diagnostic endoscopic procedure
PROCEDURE	esophagogastroduodenoscopy
PROCEDURE	tethered capsule endoscopy

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-12-01
• First posted: 2009-05-18
• Last updated: 2014-01-10

Locations

1 site across 1 country: United States