Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus - NCT00903136-98108 (Clinical Trial 292852)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy292852.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Seattle |
|
State:
|
|
WA |
| Zip Code: |
|
98108 |
| Conditions: |
|
Esophageal Cancer - Precancerous Condition |
| Purpose: |
|
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.
|
| Study summary: |
|
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 The TCE is then slowly withdrawn by the physician in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. |
| 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 |
|
|
|
| Study is available at: |
|
Veterans Affairs Medical Center - Seattle
Seattle, WA 98108
United States
Primary Contact:
Jason A. Dominitz, MD
Phone: 206-764-2285 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|