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Imaging Device

SECM Capsule Imaging for Esophageal Conditions

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
Subject must be older than 14 years of age
Must not have
Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up questionnaire adminstered directly after the imaging portion has been completed.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new endoscope that is less invasive and can be used to image the esophagus.

Who is the study for?
This trial is for healthy volunteers over 14 years old who may have or are suspected to have Eosinophilic Esophagitis (EoE). Participants must be able to swallow pills and not have esophageal strictures smaller than the capsule's diameter.
What is being tested?
The study is testing a new tool called SECM Capsule, which takes detailed images of the esophagus. The goal is to see if it's easy to use and comfortable for patients.
What are the potential side effects?
Since this trial involves imaging with an SECM Capsule, side effects might include discomfort from swallowing the capsule or potential gagging, but no drug-related side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 14 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a narrow or blocked esophagus due to a fistula or stricture.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a single 20 minute visit (5-7 minute imaging).
This trial's timeline: 3 weeks for screening, Varies for treatment, and a single 20 minute visit (5-7 minute imaging). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic Imaging
Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.

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: ImagingExperimental Treatment1 Intervention
Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,014 Previous Clinical Trials
13,309,247 Total Patients Enrolled
3 Trials studying Eosinophilic Esophagitis
132 Patients Enrolled for Eosinophilic Esophagitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,748 Total Patients Enrolled
12 Trials studying Eosinophilic Esophagitis
3,184 Patients Enrolled for Eosinophilic Esophagitis
National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,527 Total Patients Enrolled
8 Trials studying Eosinophilic Esophagitis
2,264 Patients Enrolled for Eosinophilic Esophagitis

Media Library

SECM Capsule (Imaging Device) Clinical Trial Eligibility Overview. Trial Name: NCT02202590 — N/A
Eosinophilic Esophagitis Research Study Groups: Imaging
Eosinophilic Esophagitis Clinical Trial 2023: SECM Capsule Highlights & Side Effects. Trial Name: NCT02202590 — N/A
SECM Capsule (Imaging Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02202590 — N/A
~7 spots leftby Dec 2025
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