Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
Recruitment status was: Recruiting
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.
|Esophageal Cancer Precancerous Condition||Other: questionnaire administration Procedure: comparison of screening methods Procedure: diagnostic endoscopic procedure Procedure: esophagogastroduodenoscopy Procedure: tethered capsule endoscopy||Phase 1 Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Screening
|Official Title:||Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope|
- 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)
- 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)
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903136
|United States, Washington|
|Veterans Affairs Medical Center - Seattle||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Jason A. Dominitz, MD 206-764-2285|
|Principal Investigator:||Jason A. Dominitz, MD||VA Office of Research and Development|