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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastrointestinal Disease
• Intervention / Treatment: Device: Cryobiopsy probe, administered to study participants

Detailed Description

This study will test the capacity of a gastrointestinal tract cryobiopsy probe that Tearney Lab investigators have designed to obtain biopsies from the upper GI tract.

A total of twenty (20) subjects, adults 18 years of age and older, scheduled for elective esophagogastroduodenoscopy with biopsy will be enrolled in this study.

A maximum of 3 cryobiopsies per subject will be collected. After each cryobiopsy is complete, the endoscopist will then take 1 standard forceps biopsy from the area adjacent to where cryobiopsy was performed. A maximum of 3 standard forceps biopsies for research purposes only will be taken. Biopsy collection will be performed at the discretion of the endoscopist. The standard forceps biopsy sites will also be monitored directly throughout the entire experimental procedure. The total experimental procedure time will not exceed 15 minutes.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryobiopsy probe as a tool for biopsy; 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; Cryobiopsy probe as a tool for gastrointestinal biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Cryobiopsy probe	Evaluation of Cryobiopsy probe in obtaining tissue samples over .5mm	3 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Guillermo Tearney, M.D PhD., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: OCT; Biopsy; Endoscopy; EGD; Cryobiopsy
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2018-P000734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No