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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: Recruiting Phase 2 study of Peripheral Nerve Injuries, sponsored by Major Extremity Trauma Research Consortium.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Complications or problems include surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
What NCT04789044 shows while recruiting
NCT04789044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 457-participant average among 8 other Peripheral Nerve Injuries trials with a reported enrollment target (91% lower).
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 lists 7 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Peripheral Nerve Injuries
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Where NCT04789044's enrollment target sits among peer trials
40 8th of 8 higher than 1 of 8 other Peripheral Nerve Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Nerve Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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