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Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
Conditions
Esophageal Cancer - Precancerous Condition
Conditions: official terms
Barrett Esophagus - Esophageal Neoplasms - Precancerous Conditions
Conditions: Keywords
Barrett esophagus, esophageal cancer, adenocarcinoma of the esophagus
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Masking: Open Label, Primary Purpose: Screening
Intervention
Name: questionnaire administration
Type: Other
Name: comparison of screening methods
Type: Procedure
Name: diagnostic endoscopic procedure
Type: Procedure
Name: esophagogastroduodenoscopy
Type: Procedure
Name: tethered capsule endoscopy
Type: Procedure
Overall Status
Recruiting
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.
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 The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is reached.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.
- 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
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
Status: Recruiting
Contact: Jason A. Dominitz, MD - 206-764-2285
Start Date
May 2009
Sponsors
Department of Veterans Affairs
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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