Recruiting
Phase 2

PEG Fusion

Sponsor:

Major Extremity Trauma Research Consortium

Code:

NCT04789044

Conditions

Peripheral Nerve Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NTX-001

Study Details

Brief 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

Peripheral Nerve Injuries

Study ID

NCT04789044

Start date

Jun 1, 2023

Status verified date

Feb, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Ages 18-80
2. Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
3. Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist
4. Involves a "mixed" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present).

Exclusion Criteria:

1. Patients beginning surgery within hours after injury.
2. Injury to the brachial plexus nerves
3. Injury to the nerves distal to the distal flexion crease of the wrist
4. Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN).
5. Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
6. Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
7. Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
8. Not expected to survive the next 30 days due to their injuries/health condition.
9. The subject has a known allergy to polyethylene glycol (PEG).
10. If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is > 10 mm on the CL side during baseline period, the subject is a screen failure.
11. The subject is pregnant and/or is breastfeeding.
12. The subject has a significant medical comorbidity precluding immediate repair.
13. The subject is not able to strictly adhere to the rules of the current clinical protocol.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PEG mediated reconstruction

NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy.

no intervention: Conventional nerve reconstruction

Conventional nerve reconstruction

Interventions

NTX-001

• PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity.

Primary outcome measure

  • Complications or problems that occur with in the first 30 days. [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

Elizabeth Wysocki, MA

410-955-0396ewysock2@jhu.edu

Ala Elhelali, PhD

443-220-2537aelhela1@jhmi.edu

Locations

University of Maryland Medical Center Shock Trauma Center

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Ray Pensy, MD

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21213

Principal Investigator:

Jaimie Shores, MD

Cooper Health

Recruiting

Camden, New Jersey, United States, 08103

Contacts

gentile-pietro@CooperHealth.edu

Principal Investigator:

David Fuller, MD

OrthoCarolina

Recruiting

Charlotte, North Carolina, United States, 28207

Principal Investigator:

Glenn Gaston, MD

Wellspan Health

Recruiting

York, Pennsylvania, United States, 17403

Principal Investigator:

Richard Trevino, MD

San Antonio Military Medical Center (SAMMC)

Recruiting

San Antonio, Texas, United States, 78234

Principal Investigator:

Jason Alderete, MD

Virginia Commonwealth University Medical Center

Recruiting

Richmond, Virginia, United States, 23219

Principal Investigator:

Jonathan Issacs, MD

More Information

Sponsor

Major Extremity Trauma Research Consortium

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Major Extremity Trauma Research Consortium on 2026-02-27.