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Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Aug 31, 2026 to May 3, 2026
    • Study completion pushed from Aug 31, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 11 words
    • Publications: details revised at 19 of 21 entries
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary and study completion pushed from May 31, 2026 to Aug 31, 2026
    • Site details revised
    v11
  3. Primary and study completion dates: Mar 2, 2026 to May 31, 2026
    • Study description shortened, about 5 words
    v10
  4. Eligibility criteria shortened, about 10 words
    • Study description expanded, about 26 words
    v9
  5. Interventions: Placebo (Other), ReliZORB™ (Device) to Placebo (Other), RELiZORB™ (Device)
    • Primary endpoint revised
    • Study description revised
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 14, 2025 to May 7, 2025
    • Site details revised
    v7
  2. Start date: Mar 1, 2025 to Apr 14, 2025
    • Primary and study completion dates: Feb 2, 2026 to Mar 2, 2026
    v6
  3. Phase: Phase 4 to Not applicablev5 Show 14 more changesShow less
    • Lead sponsor: Duke University to Inova Health Care Services
    • Trial status: Withdrawn to Not Yet Recruiting
    • Primary completion date: Jul 30, 2023 to Feb 2, 2026
    • Start date: May 1, 2023 to Mar 1, 2025
    • Primary endpoint revised
    • Enrollment target: 0 to 32
    • Study completion date: Jan 30, 2024 to Feb 2, 2026
    • Interventions: Placebo (Other), Relizorb (Drug) to Placebo (Other), ReliZORB™ (Device)
    • Eligibility criteria expanded, about 124 words
    • Secondary endpoints: 10 to 3
    • Study description expanded, about 143 words
    • Study site revised
    • Study title expanded, about 6 words
    • Collaborators expanded, about 3 words
  4. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: PI initiated study closure. He will be leaving the study site for a new position in the coming months.
    • Enrollment target: estimated 32 to confirmed 0
    • Site contact updated
    v4
  5. Start date: Mar 15, 2023 to May 1, 2023v3
  6. Phase: Not applicable to Phase 4
    • Start date: Feb 15, 2023 to Mar 15, 2023
    v2
  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.
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion. RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.
Trial Details
NCT Number NCT05710315
Lead Sponsor Inova Health Care Services
Collaborators: Alcresta Therapeutics, Inc.
Conditions
(from sponsor)		 Multi Organ Failure, Exocrine Pancreatic Insufficiency
Related terms Exocrine Pancreatic Insufficiency, Multiple Organ Failure
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov