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SECM Capsule Imaging for Eosinophilic Esophagitis

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
12 years of age or older undergoing endoscopic biopsy for evaluation of EoE
Must not have
Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule
Inability to swallow pills and capsules
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
No Placebo-Only Group

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.
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.
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 below
Select...
I am 12 or older and getting a biopsy to check for EoE.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a narrow or blocked esophagus smaller than a capsule.
Select...
I cannot swallow pills or capsules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes (roughly the amount of time it takes to image the esophagus via secm capsule)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes (roughly the amount of time it takes to image the esophagus via secm capsule) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of imaging of the Esophagus using a SECM Capsule

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: 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
3,026 Previous Clinical Trials
13,413,739 Total Patients Enrolled
Guillermo Tearney, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
8 Previous Clinical Trials
1,095 Total Patients Enrolled

Media Library

SECM capsule Clinical Trial Eligibility Overview. Trial Name: NCT03546660 — N/A
Barrett's Esophagus Research Study Groups: SECM capsule imaging
Barrett's Esophagus Clinical Trial 2023: SECM capsule Highlights & Side Effects. Trial Name: NCT03546660 — N/A
SECM capsule 2023 Treatment Timeline for Medical Study. Trial Name: NCT03546660 — N/A
~40 spots leftby Dec 2026