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NCT03566160 · ClinicalTrials.gov registry record · NA

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

A NA study of Gastrointestinal Disease, sponsored by Massachusetts General Hospital.

Active
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT03566160 is a NA study of Gastrointestinal Disease that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 2,412-participant average among 7 other Gastrointestinal Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03566160, a NA study of Gastrointestinal Disease, is active but no longer recruiting, sponsored by Massachusetts General Hospital.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • DEVICE Cryobiopsy probe, administered to study participants

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-09-05
Est. Completion 2027-12-30
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT03566160

The ClinicalTrials.gov registry entry for NCT03566160 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,412-participant average among 7 other Gastrointestinal Disease trials with a reported enrollment target (99% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gastrointestinal Disease appearing as the primary indexed condition, and to 1 intervention - of which Cryobiopsy probe, administered to study participants is the first listed.

NCT03566160 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT03566160 about?

NCT03566160 is a clinical study titled "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, stu...

What is the current status of trial NCT03566160?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2018-09-05. Estimated completion is 2027-12-30.

What conditions does trial NCT03566160 study?

This clinical trial studies the following conditions: Gastrointestinal Disease.

What interventions are being tested in trial NCT03566160?

The interventions under investigation include: Cryobiopsy probe, administered to study participants (DEVICE).

Who is sponsoring clinical trial NCT03566160?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03566160 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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