Clinical trial · Interventional
Tethered Capsule Endoscope in Screening Patients With Barrett Esophagus
Use of a Tethered Capsule Endoscope in Screening for Barrett's Esophagus
- 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)
This pilot clinical trial studies how well tethered capsule endoscope works in screening patients with Barrett esophagus (BE), a condition where the lining of the esophagus has changed or has been replaced with abnormal cells that may lead to cancer also called esophageal cancer. In an attempt to prevent the progression from BE to esophageal cancer, patients undergo a standard procedure called esophagogastroduodenoscopy (EGD) where patients are sedated and the doctor uses an endoscope to examine the tissue in the esophagus. Tethered capsule endoscope is a tiny capsule with a laser scan inside and a very thin cord attached to it. Patients swallow the capsule and the thin cord keeps the capsule in specific area in the esophagus. After pictures of the lining of esophagus are taken, the capsule is removed using the thin cord. Tethered capsule endoscope may be able to identify tissue changes in patients with BE without the need for sedation or anesthesia, thus eliminating the associated risks and costs associated with EGD.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey Administration | Other | — | UNRESOLVED |
| Tethered Capsule Endoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (TCE)
- description
- Patients swallow the TCE and undergo endoscopic examination while they are seated on a standard endoscopy gurney. Patients undergo standard of care EGD on the same day.
- interventionNames
- Other: Survey Administration
- Device: Tethered Capsule Endoscope
Primary outcomes (3)
- measure
- Consistent image quality
- timeFrame
- At the conclusion of TCE exam (day 1)
- description
- Consistent image quality defined as no significant degradation of lateral spatial resolution \[line pairs per mm\] and axial depth of focus \[mm\], maximum field of view \[degrees cone angle\], and color fidelity \[qualitatively matches color chart\] when measured after use in the clinic using color and resolution test targets and a test chamber to measure field of view. The standard care EGD will be digitally recorded to allow for review and comparison to the TCE procedure by a blinded, expert endoscopist.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ability and willingness to provide written informed consent * Scheduled for endoscopic screening and/or evaluation of Barrett's esophagus Exclusion Criteria: * Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum * Symptoms of dysphagia * Suspicion or known history of gastrointestinal obstruction * History of prior surgery on the oropharynx, neck, esophagus, or stomach * Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness * Currently taking anticoagulant medications or clopidogrel * Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position * Inability to abstain from taking anything by mouth for at least 6 hours * Currently pregnant * Expected to undergo magnetic resonance imaging (MRI) within two weeks following the study procedure
References
Publications (0)
Data not yet available