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Clinical Trial

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

NCT: NCT03566160 · ACTIVE_NOT_RECRUITING

NCT IDNCT03566160
StatusACTIVE_NOT_RECRUITING
Start Date2018-09-05
Completion2030-12-30
SponsorMassachusetts General Hospital (OTHER)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy is a clinical trial registered under NCT03566160. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT03566160?

The current status of NCT03566160 (Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy) is: ACTIVE_NOT_RECRUITING.

When did Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy start?

Pilot Study for Evaluation of Cryobiopsy and Correlation With Standard Forceps Biopsy started on 2018-09-05.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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