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NCT04789044 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Peripheral Nerve Injuries, sponsored by Major Extremity Trauma Research Consortium.

Recruiting
Registry status
Phase 2
Development phase
40
Enrollment target
7
Study locations

NCT04789044 is a Phase 2 study of Peripheral Nerve Injuries that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 40 participants, below the 457-participant average among 8 other Peripheral Nerve Injuries trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 6 states.

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The verdict

NCT04789044, a Phase 2 study of Peripheral Nerve Injuries, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.

RECRUITING
Registry status
Phase 2
Development phase
40 participants
Enrollment target
7
Study locations

Study Summary

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.

Conditions Studied

Peripheral Nerve Injuries

Interventions

  • DRUG NTX-001

Study Locations (7)

Maryland

  • University of Maryland Medical Center Shock Trauma Center - Baltimore
  • Johns Hopkins University School of Medicine - Baltimore

New Jersey

  • Cooper Health - Camden

North Carolina

  • OrthoCarolina - Charlotte

Pennsylvania

  • Wellspan Health - York

Texas

  • San Antonio Military Medical Center (SAMMC) - San Antonio

Virginia

  • Virginia Commonwealth University Medical Center - Richmond

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-06-01
Est. Completion 2028-10-01
Phase Phase 2

Sponsor

Major Extremity Trauma Research Consortium

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04789044

The ClinicalTrials.gov registry entry for NCT04789044 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 457-participant average among 8 other Peripheral Nerve Injuries trials with a reported enrollment target (91% lower). The listed sponsor is Major Extremity Trauma Research Consortium, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral Nerve Injuries appearing as the primary indexed condition, and to 1 intervention - of which NTX-001 is the first listed.

NCT04789044 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Maryland, New Jersey, North Carolina.

Frequently Asked Questions

What is clinical trial NCT04789044 about?

NCT04789044 is a clinical study titled "Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)". 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 c...

What is the current status of trial NCT04789044?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-06-01. Estimated completion is 2028-10-01.

What conditions does trial NCT04789044 study?

This clinical trial studies the following conditions: Peripheral Nerve Injuries.

What interventions are being tested in trial NCT04789044?

The interventions under investigation include: NTX-001 (DRUG).

Who is sponsoring clinical trial NCT04789044?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04789044 being conducted?

This trial has 7 study locations across Maryland, New Jersey, North Carolina, Pennsylvania, Texas. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.