NCT03566160

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

Active, enrolled NA Last updated 22 October 2025

What this trial tests

NA trial testing Cryobiopsy probe, administered to study participants in Gastrointestinal Disease in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 September 2018

Primary endpoint
30 December 2026

30 December 2027

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	30
Start date	5 September 2018
Primary completion	30 December 2026
Estimated completion	30 December 2027
Sites	1 location across United States

Drugs / interventions tested

• Cryobiopsy probe, administered to study participants

Conditions studied

• Gastrointestinal Disease — all drugs for Gastrointestinal Disease →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Gastrointestinal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.