Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope
- 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.
- 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 The TCE is then slowly withdrawn by the physician in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
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.
Masking: Open Label, Primary Purpose: Screening
Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)
Jason A. Dominitz, MD
Department of Veterans Affairs
|Veterans Affairs Medical Center - Seattle||Seattle, Washington 98108|