Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy
NCT ID: NCT03566160
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2018-09-05
2027-12-30
Brief Summary
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Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic. In order to prevent the deleterious and permanent sequelae of the disease, there is a need for effective diagnosis and intervention to be implemented in EED patients before the age of 2. Currently, the only means for directly evaluating the intestine is endoscopy with mucosal biopsy. Unfortunately, endoscopy is untenable for the study of EED because of limited resources and the high cost. As a result, there is a clear, unmet need for a less invasive tool that can be used in low-and-middle-income-countries (LMICs) to evaluate the intestine in population with EED.
This work is supported by a grant from The Bill and Melinda Gates Foundation (BMGF). The overall goal is to provide a minimally invasive means of obtaining detailed infantile intestinal tissue information that is needed for the development of effective EED interventions. Obtaining biopsies will play a critical role in gathering the detailed intestinal tissue information.
The purpose of this study is to explore the feasibility of utilizing a cryobiopsy probe to obtain biopsies in adults.
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Detailed Description
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A total of twenty (20) participants, adults 18 years of age and older, scheduled for elective esophagogastroduodenoscopy with biopsy will be enrolled in this study.
A maximum of 3 cryobiopsies per subject will be collected. After each cryobiopsy is complete, the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed. A maximum of 3 standard forceps biopsies for research purposes only will be taken. Biopsy collection will be performed at the discretion of the endoscopist. The standard forceps biopsy sites will also be monitored directly throughout the entire experimental procedure. The total experimental procedure time will not exceed 15 minutes.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Cryobiopsy probe as a tool for biopsy
Cryobiopsy probe, administered to study participants.Testing the efficacy of a novel cryobiopsy probe in acquiring tissue samples.
Cryobiopsy probe, administered to study participants
Cryobiopsy probe as a tool for gastrointestinal biopsy
Interventions
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Cryobiopsy probe, administered to study participants
Cryobiopsy probe as a tool for gastrointestinal biopsy
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older.
* Able to provide informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Guillermo Tearney
Principal Investigator
Principal Investigators
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Guillermo Tearney, M.D PhD.
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2018-P000734
Identifier Type: -
Identifier Source: org_study_id
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