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Active Not Recruiting NCT03566160

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

Conditions: Gastrointestinal Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

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.

Eligibility Criteria

Inclusion Criteria: * Scheduled for an elective esophagogastroduodenoscopy with biopsy. * 18 years of age or older. * Able to provide informed consent. Exclusion Criteria: * According to standard of care.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03566160). StuddyBuddy aggregates publicly available trial information.