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

NCT03566160 | Active Not Recruiting FDA Device

• 1 other identifier: 2018-P000734
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disease

Keywords

Biopsy; EGD; Endoscopy; Cryobiopsy; OCT

Outcome Measures

Primary Outcomes (1)

• Evaluation of Cryobiopsy probe

  Evaluation of Cryobiopsy probe in obtaining tissue samples over .5mm

  3 years

Study Arms (1)

Cryobiopsy probe as a tool for biopsy

EXPERIMENTAL

Cryobiopsy probe, administered to study participants.Testing the efficacy of a novel cryobiopsy probe in acquiring tissue samples.

Device: Cryobiopsy probe, administered to study participants

Interventions

Cryobiopsy probe, administered to study participants DEVICE

Cryobiopsy probe as a tool for gastrointestinal biopsy

Cryobiopsy probe as a tool for biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for an elective esophagogastroduodenoscopy with biopsy.
• years of age or older.
• Able to provide informed consent.

You may not qualify if:

• According to standard of care.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Guillermo Tearney, M.D PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 25, 2018
• Study Start: September 5, 2018
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)