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Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Site details revised at 7 of 7 sites
    v10
  2. Primary completion date: Oct 1, 2025 to Oct 1, 2027
    • Study completion date: Oct 1, 2026 to Oct 1, 2028
    • Study sites revised (7)
    v9
  3. Primary completion date: Oct 1, 2024 to Oct 1, 2025
    • Study completion date: Oct 1, 2024 to Oct 1, 2026
    • Site contacts updated at 7 of 7 sites
    v8
  4. Secondary endpoints shortened, about 15 wordsv7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 7 of 7 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Apr 1, 2023 to Jun 1, 2023v5
  2. Start date: Feb 1, 2023 to Apr 1, 2023v4
  3. Start date: Oct 1, 2022 to Feb 1, 2023v3
  4. Start date: Oct 1, 2021 to Oct 1, 2022
    • Eligibility criteria revised
    • Study description shortened, about 78 words
    • Study arms: 4 to 2
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.
Trial Details
NCT Number NCT04789044
Lead Sponsor Major Extremity Trauma Research Consortium
Collaborators: United States Department of Defense
Conditions
(from sponsor)		 Peripheral Nerve Injuries
Related terms Peripheral Nerve Injuries
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov