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RECRUITING Phase 2

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

NCT04789044 · View on ClinicalTrials.gov ↗

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

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04789044 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Maryland, New Jersey, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04789044?

The interventions under investigation include: NTX-001 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04789044?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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