Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| VAMC-WA-33141 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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:
OUTLINE:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | |||
| comparison of screening methods | Procedure | |||
| diagnostic endoscopic procedure | Procedure | |||
| esophagogastroduodenoscopy | Procedure | |||
| tethered capsule endoscopy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
DISEASE CHARACTERISTICS:
Meets one of the following criteria:
No current diagnosis of cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jason A. Dominitz, MD | VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Seattle | Recruiting | Seattle | Washington | 98108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D011230 | Precancerous Conditions |
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
Not provided
Not provided