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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 30, 2026 → Dec 30, 2028
See other at-risk trials from Massachusetts General Hospital

Record History

  1. Primary completion pushed from Dec 30, 2026 to Dec 30, 2028 Completion pushed from Dec 30, 2027 to Dec 30, 2030 · Eligibility criteria expanded, about 4 words Show 2 more changesShow less
    • Completion pushed from Dec 30, 2027 to Dec 30, 2030
    • Eligibility criteria expanded, about 4 words
  2. Primary completion date: Dec 30, 2025 to Dec 30, 2026 Completion date: Dec 30, 2026 to Dec 30, 2027 · Study description revisedv10 Show 2 more changesShow less
    • Completion date: Dec 30, 2026 to Dec 30, 2027
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 20 to 30 Primary completion date: Dec 30, 2023 to Dec 30, 2025 · Trial status: Enrolling by Invitation to Active, Not Recruiting · Completion date: Dec 30, 2024 to Dec 30, 2026v9 Show 3 more changesShow less
    • Primary completion date: Dec 30, 2023 to Dec 30, 2025
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Completion date: Dec 30, 2024 to Dec 30, 2026
  4. Primary completion date: Dec 30, 2022 to Dec 30, 2023 Completion date: Dec 30, 2023 to Dec 30, 2024v8 Show 1 more changeShow less
    • Completion date: Dec 30, 2023 to Dec 30, 2024
  5. Primary completion date: Sep 30, 2021 to Dec 30, 2022 Completion date: Sep 30, 2022 to Dec 30, 2023v7 Show 1 more changeShow less
    • Completion date: Sep 30, 2022 to Dec 30, 2023
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: Sep 30, 2020 to Sep 30, 2021 Completion date: Sep 30, 2021 to Sep 30, 2022v6 Show 1 more changeShow less
    • Completion date: Sep 30, 2021 to Sep 30, 2022
  2. Trial status: Recruiting to Enrolling by Invitation Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 30, 2018 to Sep 5, 2018v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2018 to Sep 5, 2018
  4. Start date: Jul 30, 2018 to Sep 30, 2018 Primary completion date: Jul 30, 2020 to Sep 30, 2020 · Completion date: Jul 30, 2021 to Sep 30, 2021v3 Show 2 more changesShow less
    • Primary completion date: Jul 30, 2020 to Sep 30, 2020
    • Completion date: Jul 30, 2021 to Sep 30, 2021
  5. Study description expanded, about 2 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03566160
Lead Sponsor Massachusetts General Hospital
Collaborators: Bill and Melinda Gates Foundation
Conditions Gastrointestinal Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov