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Tethered Capsule Endomicroscopy for Barrett's Esophagus
N/A
Waitlist Available
Led By Guillermo Tearney, MD, 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
Subjects over the age of 18
Subjects with a diagnosis of BE without high grade dysplasia, intramucosal adenocarcinoma or esophageal adenocarcinoma, confirmed by endoscopic biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial will study whether a tethered capsule endomicroscopy device can help doctors detect and treat Barrett's Esophagus.
Who is the study for?
This trial is for adults over 18 with Barrett's Esophagus (BE) but without severe cell changes or esophageal cancer. Participants must not eat solid food for at least 4 hours and only clear liquids for 2 hours before the procedure. They should be able to swallow capsules, give informed consent, and have had a standard EGD within the past 15 months.Check my eligibility
What is being tested?
The study tests Tethered Capsule Endomicroscopy (TCE), a less invasive way to monitor Barrett's Esophagus using a capsule device with imaging technology. Patients will be followed up for three years at multiple sites to see how well TCE works in detecting changes in the esophagus.See study design
What are the potential side effects?
Potential side effects of TCE may include discomfort from swallowing the capsule, gagging, or choking if difficulty swallowing occurs. There might also be risks associated with sedation if used during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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I have Barrett's esophagus without severe changes or cancer, confirmed by a biopsy.
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I have had or will have a standard EGD test within 15 months.
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I am able to understand and agree to the study's procedures and risks.
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I haven't eaten solid food for 4 hours and only had clear liquids for 2 hours before the procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental OFDI capsule imagingExperimental Treatment1 Intervention
Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI imaging system.
Intervention: 'Tethered Capsule Endomicroscopy (TCE) Imaging of Barrett's esophagus using OFDI capsule
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,177 Previous Clinical Trials
3,757,861 Total Patients Enrolled
Kansas City Veteran Affairs Medical CenterFED
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8,068 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,613 Previous Clinical Trials
40,917,825 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I have an esophageal fistula or stricture.I have Barrett's esophagus without severe changes or cancer, confirmed by a biopsy.I have had a procedure to remove or destroy Barrett's esophagus.I have had or will have a standard EGD test within 15 months.I am able to understand and agree to the study's procedures and risks.You are unable to swallow pill capsules.I haven't eaten solid food for 4 hours and only had clear liquids for 2 hours before the procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental OFDI capsule imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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