Imaging of the Esophagus Using a SECM Capsule
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eosinophilic esophagitis is an inflammatory condition of the esophagus that occurs in response to certain foods or allergens. Approximately 300,000 people in the US have EoE, the incidence of newly diagnosed EoE is ~30,000/year, and EoE is found in 5-10% of all patients undergoing upper endoscopy. EoE is associated with debilitating symptoms, and is a common cause of dysphagia, strictures, and food impaction; it may even lead to esophageal perforation. Because of the impact of EoE on quality of life as well as the concern that this disease may progress to esophageal fibrosis with unknown long-term risks, experts recommend that EoE be treated until symptoms and eosinophilic infiltrate are resolved. Because the only objective method for diagnosing EoE is histopathologic assessment of multiple upper endoscopic biopsies, the processes of monitoring the esophagus during therapy and the food reintroduction involve a high number of repeat endoscopies. This process is both time consuming and frustrating for patients and their families. Because the endoscopic biopsy requires conscious sedation, it is also costly, exceeding $1000 per procedure. Given the rapid increase in the number of patients with this disease, there is a compelling need for a less invasive and more cost-effective means of identifying eosinophils in the esophagus.
Based on the extensive experience with Optical Coherence Tomography (OCT) and OFDI, the investigators at Tearney laboratory at MGH have developed a spectrally encoded confocal microscopy (SECM) technology that is able to acquire images at significantly higher frame rates than standard confocal microscopy. This SECM capability enables imaging of large portions of the esophagus at 2-µm resolution in realistic procedure times. Furthermore, the investigators at Tearney laboratory have created a tethered capsule SECM device that can be swallowed and used for EoE screening. The investigators at Tearney laboratory lab performed a pilot study using a SECM capsule on 58 subjects (2013-P-000863). The imaging was successful with no adverse or unanticipated events. SECM endoscopy capsule is similar to the approved endoscopy capsule.
A total of sixty (60) subjects will be recruited for this study. The imaging of the esophagus will be obtained. Subjects will not be sedated for the procedure.
The images obtained by the SECM capsule will be compared to the images obtained by the clinical endoscopy and biopsy. SECM imaging will be used for research purposes only and will not be used for diagnosis purposes.
Study Type
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
Description
Inclusion Criteria:
- Participants 18 years of age or older who are healthy and have no significant health related issues
- Participants 14 years of age of older who are undergoing evaluation for EoE
- Able to give informed consent or assent as per the age of the subject
Exclusion Criteria:
- 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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SECM capsule imaging
Participant will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system
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Participants will swallow a SECM capsule and the SECM imaging will be performed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of imaging of the Esophagus using a SECM Capsule
Time Frame: 10 minutes (roughly the amount of time it takes to image the esophagus via SECM capsule)
|
comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.
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10 minutes (roughly the amount of time it takes to image the esophagus via SECM capsule)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillermo Tearney, MD, PhD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Hypersensitivity, Immediate
- Hypersensitivity
- Eosinophilia
- Leukocyte Disorders
- Hematologic Diseases
- Esophageal Diseases
- Gastroenteritis
- Precancerous Conditions
- Esophagitis
- Hemic and Lymphatic Diseases
- Eosinophilic Esophagitis
- Barrett Esophagus
Other Study ID Numbers
- 2018-P000844
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
product manufactured in and exported from the U.S.
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