- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02202590
Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus
Pilot Study to Image the Esophagus Using Spectrally Encoded Confocal Microscopy (SECM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
72 subjects including healthy volunteers, patients with a suspicion of having Eosinophilic Esophagitis (EoE) and patients with a clinical diagnosis of EoE will be recruited and asked to swallow the SECM capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.
As the capsule progresses, multiple 2-dimensional cross sectional images of the esophagus are acquired. Images are analyzed at a later stage.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject must be a healthy volunteer
- OR subject must have a suspicion of EoE
- OR subject must have a prior clinical suspicion of EoE
- Subject must be older than 14 years of age
- Subject must be able to give informed consent
Exclusion Criteria:
- Subjects with the inability to swallow pills and capsules.
- Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imaging
Subject will swallow the SECM capsule and Imaging will be performed using the SECM Imaging system.
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Imaging of the esophagus using the SECM capsule and system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SECM Imaging quality. Assessed qualitative values like resolution, tissue architecture, background scatter etc.
Time Frame: A single 20 minute visit (5-7 minute imaging).
|
An investigator will qualitatively assess the the Feasibility of SECM Capsule and Imaging in EoE participant versus Healthy Controls.
He will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed.
The images obtained by the SECM Capsule will be compared to the images obtained by clinical endoscopy if available.
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A single 20 minute visit (5-7 minute imaging).
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Tolerability of SECM Capsule Imaging Procedure in Healthy and EoE Participant, measured by feedback scores.
Time Frame: Questionnaire adminstered directly after the imaging portion has been completed.
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After participating in the study, the subject will be asked for feedback about tolerability of the procedure using a questionnaire.
This entails questions about discomfort levels and the participants ability to tolerate the tether and capsule during the whole and parts of the procedures.
using a 0 -10 scale, participants will score how comfortable the procedure was during each stage.
10 being the most discomfort and 0 being the least discomfort.
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Questionnaire adminstered directly after the imaging portion has been completed.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Guillermo Tearney, MD., PhD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-P000863
- 5R01DK091923-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ShireCompleted
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Clinical Trials on SECM Capsule
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Quan JiangUnknown
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Yung Shin Pharm. Ind. Co., Ltd.Changhua Christian HospitalCompletedHot Flashes | PMSTaiwan
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Chipscreen Biosciences, Ltd.Not yet recruiting
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Burapha UniversityCompletedAsparagus Capsule ConsumptionThailand