Clinical trial · Interventional
Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus
Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope
NCT00903136CI-TRIAL-00013383unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comparison of screening methods | Procedure | — | UNRESOLVED |
| diagnostic endoscopic procedure | Procedure | — | UNRESOLVED |
| esophagogastroduodenoscopy | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| tethered capsule endoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (13)
- measure
- Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)
- measure
- Time required to image the squamo-columnar junction (Phase I)
- measure
- Number of repeated swallows to achieve esophageal imaging (Phase I)
- measure
- Amount of simethicone needed to reduce bubbles (Phase I)
- measure
- Need for effervescent granules or other approaches to distend the esophagus (Phase I)
- measure
- Time required for the entire TCE procedure (Phase I)
- measure
- Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.