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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging data is collected during the procedure, and analyzed within 1 year of collection.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prevalence of Barrett's esophagus within the single Primary Care Practice cohort.
Subject Tolerability of Tethered Capsule Endomicroscopy Swallow
Trial Design
1Treatment groups
Experimental Treatment
Group I: Feasibility of TCE & Prevalence of BEExperimental Treatment1 Intervention
Feasibility of using tethered capsule endomicroscopy as a screening method for Barrett's esophagus in the primary care practice environment
Determine the prevalence of Barrett's esophagus in a primary care practice cohort at MGH
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,635 Total Patients Enrolled
Guillermo Tearney, M.D, PhD.Principal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
440 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently having difficulty swallowing.I am 18 years old or older.I have a narrow GI passage, had GI surgery, or have Crohn's disease.I am scheduled for an urgent care visit due to symptoms like fever or abdominal pain.I am older than 75 years.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Feasibility of TCE & Prevalence of BE
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.
Is access to this research endeavor currently available for participants?
"Clinicaltrials.gov confirms that this medical trial is no longer accepting new participants, though it was initially posted on the 2nd of January 2019 and last updated on September 22nd 2020. Nonetheless, there are 36 other clinical trials actively searching for patients right now."
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