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

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03566160
• Other study ID #: 2018-P000734
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Device:
• Cryobiopsy probe, administered to study participants
Cryobiopsy probe as a tool for gastrointestinal biopsy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Cryobiopsy probe	Evaluation of Cryobiopsy probe in obtaining tissue samples over .5mm	3 years