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Endoscopy

Tethered Capsule Endomicroscopy for Barrett's Esophagus

N/A

Waitlist Available

Led By Guillermo Tearney, M.D, PhD.

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years or older

Be older than 18 years old

Must not have

Subjects with current symptoms of dysphagia

Subjects with gastro-intestinal strictures with a diameter less than 8mm, prior GI surgery (Esophageal and/or stomach surgeries), or history of intestinal Crohn's disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up imaging data is collected during the procedure, and analyzed within 1 year of collection.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new screening method for Barrett's Esophagus is feasible in a primary care clinic environment, as well as determining the prevalence of Barrett's Esophagus in patients seen at MGH.

Who is the study for?

This trial is for adults aged 18-75 who are patients at the Assembly Row primary care practice, can consent to participate, and haven't eaten for an hour before the procedure. It's not for pregnant individuals, those with swallowing difficulties, urgent symptoms like fever or abdominal pain, a history of certain GI surgeries or Crohn's disease.

What is being tested?

The study is testing tethered capsule endomicroscopy as a way to screen for Barrett's Esophagus in a regular doctor’s office setting. The goal is to see if this method works well in primary care and how common Barrett's Esophagus is among these patients.

What are the potential side effects?

Since this trial involves a non-invasive imaging technique rather than medication, side effects may be minimal but could include discomfort during the procedure or minor throat irritation afterwards.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently having difficulty swallowing.

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I have a narrow GI passage, had GI surgery, or have Crohn's disease.

Select...

I am older than 75 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ imaging data is collected during the procedure, and analyzed within 1 year of collection.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~imaging data is collected during the procedure, and analyzed within 1 year of collection.

This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging data is collected during the procedure, and analyzed within 1 year of collection. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.

Subject Tolerability of Tethered Capsule Endomicroscopy Swallow

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Feasibility of TCE & Prevalence of BEExperimental Treatment1 Intervention

1. Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment 2. Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH

0 / 4Eligibility criteria met