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Procedure

Tethered Capsule Endoscopy for Barrett's Esophagus

Phase 1 & 2
Waitlist Available
Led By Jason A. Dominitz, MD
Research Sponsored by US Department of Veterans Affairs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will compare a tethered capsule endoscope to standard sedated endoscopy for screening people for Barrett esophagus.

Who is the study for?
This trial is for healthy individuals or those scheduled for an esophagogastroduodenoscopy at the VA Puget Sound Health Care System. Participants should not be pregnant, have had prior surgery on certain parts of the throat or digestive tract, be taking blood thinners like clopidogrel, have swallowing difficulties, major illnesses like unstable heart disease or end-stage organ failure, a physical disability that limits movement from chair to bed, or plans for an MRI within two weeks post-procedure.Check my eligibility
What is being tested?
The study is evaluating how effective a tethered capsule endoscope is in screening for Barrett's esophagus compared to standard sedated endoscopy. This non-invasive procedure could potentially replace more invasive methods currently used to screen the esophagus and stomach.See study design
What are the potential side effects?
Since this trial involves a non-surgical screening tool (tethered capsule endoscope), side effects are expected to be minimal but may include discomfort during swallowing of the capsule and potential gagging. There's also a low risk of irritation to the lining of the esophagus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II)
Amount of simethicone needed to reduce bubbles (Phase I)
Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II)
+10 more
Secondary outcome measures
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)

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,596 Total Patients Enrolled
US Department of Veterans AffairsLead Sponsor
867 Previous Clinical Trials
487,800 Total Patients Enrolled
Jason A. Dominitz, MDPrincipal InvestigatorVA Puget Sound Health Care System

Media Library

Tethered Capsule Endoscope (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT00903136 — Phase 1 & 2
Esophageal Cancer Research Study Groups:
Esophageal Cancer Clinical Trial 2023: Tethered Capsule Endoscope Highlights & Side Effects. Trial Name: NCT00903136 — Phase 1 & 2
Tethered Capsule Endoscope (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00903136 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for volunteer participants to join this research protocol?

"Data listed on clinicaltrials.gov claims that this trial is not currently accepting patients, as the last update was in January of 2014. Nevertheless, there are currently 426 other trials recruiting participants."

Answered by AI

Is the minimum age for participation in this research endeavor above or below 70 years old?

"This clinical trial is enrolling individuals who are 18 years and older, yet below the age of 80."

Answered by AI

What criteria must one meet to be eligible for this clinical experiment?

"This trial permits the enrollment of 50 individuals, aged between 18 and 80, with pre-cancerous diseases. Other requisite criteria include: The absence of other major medical conditions (such as unstable cardiovascular illness or end-stage organ disease), Scheduled esophagogastroduodenoscopy on VA Puget Sound Health Care System to assess reflux symptoms including screening for Barrett's Esophagus, No existing cancer diagnosis, Not pregnant, Ability to fast 6+ hours prior to appointment time, Lack of dysphagia signs/symptoms, Absence of a swallowing disorder (e.g., scleroderma or achalasia"

Answered by AI
~3 spots leftby Mar 2025