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SECM Capsule Imaging for Eosinophilic Esophagitis
N/A
Recruiting
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
12 years of age or older undergoing endoscopic biopsy for evaluation of EoE
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes (roughly the amount of time it takes to image the esophagus via secm capsule)
Awards & highlights
Study Summary
This trial is comparing a new, non-invasive way of diagnosing a condition called eosinophilic esophagitis to the current standard of care, which involves taking a tissue sample through a scope.
Who is the study for?
This trial is for individuals aged 12 or older who are undergoing an endoscopic biopsy to evaluate Eosinophilic Esophagitis. Participants must be able to swallow pills and capsules, and cannot have esophageal strictures narrower than the capsule or esophageal fistula.Check my eligibility
What is being tested?
The study is testing a new imaging technique called SECM Tethered Capsule Endoscopy (TCE) against the standard biopsy method for diagnosing Eosinophilic Esophagitis in the esophagus.See study design
What are the potential side effects?
Potential side effects may include discomfort from swallowing the SECM capsule, risk of gagging, and possible irritation of the esophagus. However, specific side effects will depend on individual reactions to the capsule.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 or older and getting a biopsy to check for EoE.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes (roughly the amount of time it takes to image the esophagus via secm capsule)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes (roughly the amount of time it takes to image the esophagus via secm capsule)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of imaging of the Esophagus using a SECM Capsule
Trial Design
1Treatment groups
Experimental Treatment
Group I: SECM capsule imagingExperimental Treatment1 Intervention
Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,421 Total Patients Enrolled
Guillermo Tearney, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
1,095 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a narrow or blocked esophagus smaller than a capsule.I am 12 or older and getting a biopsy to check for EoE.I cannot swallow pills or capsules.
Research Study Groups:
This trial has the following groups:- Group 1: SECM 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.
Is this clinical research currently enrolling participants?
"Per clinicaltrials.gov, this medical study is no longer enrolling participants - the trial was initially posted on 1st January 2022 and last updated on 21st July 2021. However, there are 87 other trials currently open for recruitment as of now."
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