Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Adenocarcinoma

Barrett Esophagus

Precancerous Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

questionnaire administration

comparison of screening methods

diagnostic endoscopic procedure

esophagogastroduodenoscopy

tethered capsule endoscopy

Jason A. Dominitz, MD

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.

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 The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus	NCT00903136	Esophageal Canc... Precancerous Co...	questionnaire a... comparison of s... diagnostic endo... esophagogastrod... tethered capsul...	18 Years - 80 Years	National Cancer Institute (NCI)
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus	NCT00903136	Esophageal Canc... Precancerous Co...	questionnaire a... comparison of s... diagnostic endo... esophagogastrod... tethered capsul...	18 Years - 80 Years	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for tethered capsule endoscopy