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Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy

NCT03566160 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-22

No results posted yet for this study

Summary

Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate sanitation and hygiene. EED is a major driver of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection, affecting 25% of all children globally and causing over a million deaths each year.

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.

Conditions

  • Gastrointestinal Disease

Interventions

DEVICE

Cryobiopsy probe, administered to study participants

Cryobiopsy probe as a tool for gastrointestinal biopsy

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Guillermo Tearney, M.D PhD. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2026-12-30
Completion
2027-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03566160 on ClinicalTrials.gov