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N/A

PEG Fusion for Peripheral Nerve Injury

Phase 2
Recruiting
Led By Jaimie Shores, MD
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 18-80
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing whether a reagent called PEG fusion is safe for promoting nerve regeneration in humans. The trial will establish safety data and examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function.

Who is the study for?
This trial is for adults aged 18-80 with acute upper extremity peripheral nerve injuries, specifically to the axillary, radial, median, ulnar, or musculocutaneous nerves. Candidates must present within 48 hours of injury and have both sensory and motor function impairment. Exclusions include brachial plexus injuries, purely sensory nerve damage beyond the wrist, previous neurological disorders or trauma, severe psychiatric conditions that could affect follow-up compliance or pose a self-harm risk.Check my eligibility
What is being tested?
The study tests PEG fusion's safety in promoting nerve regeneration after an acute injury. Participants will undergo primary repair or reconstruction using PEG fusion to evaluate its effect on restoring sensory and motor functions. This Phase 2a trial aims to provide safety data and preliminary evidence for a larger efficacy trial.See study design
What are the potential side effects?
Specific side effects are not listed but participants with known allergies to polyethylene glycol (PEG) are excluded from the trial suggesting potential allergic reactions as a concern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have nerve damage in my arm between my shoulder and wrist.
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I have a recent complete nerve injury in my arm from an accident.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complications or problems that occur with in the first 30 days.
Secondary outcome measures
Grip Strength
Motor Function
Pain Score
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PEG mediated reconstructionExperimental Treatment1 Intervention
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.
Group II: Conventional nerve reconstructionActive Control1 Intervention
Conventional nerve reconstruction

Find a Location

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor
31 Previous Clinical Trials
27,338 Total Patients Enrolled
United States Department of DefenseFED
861 Previous Clinical Trials
227,154 Total Patients Enrolled
Jaimie Shores, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
280 Total Patients Enrolled

Media Library

NTX-001 (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04789044 — Phase 2
Peripheral Nerve Injury Research Study Groups: PEG mediated reconstruction, Conventional nerve reconstruction
Peripheral Nerve Injury Clinical Trial 2023: NTX-001 Highlights & Side Effects. Trial Name: NCT04789044 — Phase 2
NTX-001 (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789044 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper age limit for participants in this research endeavor?

"As indicated by the admission criteria, this clinical trial is available to individuals ranging from 18 years old to 80. Additionally, there are 3 trials for minors and 12 studies that focus on patients over 65."

Answered by AI

Is there an opportunity for me to join this clinical experiment?

"This research trial is open to 40 individuals of legal age who have experienced a peripheral nerve injury. These applicants must have endured an upper extremity trauma within 48 hours and be affected by damage or dysfunction in the axillary, radial, median, ulnar, or musculocutaneous nerves located between the proximal humerus and distal flexion crease of their wrist. Furthermore, these injuries need to involve both motor and sensory neurons at the same location (i.e., mixed nerve segment)."

Answered by AI

Are numerous medical centers facilitating this research endeavor in North America?

"At the present moment, there are 7 clinical sites accepting participants for this medical trial. These locations include Baltimore, San Antonio and Charlotte with 4 other cities also in consideration. To reduce travel burden, you should select a site as close to your home as possible."

Answered by AI

Has NTX-001 achieved certification from the FDA?

"Power researchers assessed NTX-001's safety at a score of 2 due to its Phase 2 trial status; there is data attesting to the drug's security, but none yet pointing towards effectiveness."

Answered by AI

Are there any opportunities to join this medical experiment at the present time?

"Per the information shared on clinicaltrials.gov, this trial is not actively recruiting—the initial posting was made in February 1st 2023 and the last update to its status occurred November 29th 2022. However, there are 13 alternative trials that are currently open for enrolment."

Answered by AI

Who else is applying?

What state do they live in?
California
Maryland
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
University of Maryland Medical Center Shock Trauma Center
San Antonio Military Medical Center (SAMMC)
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
2023. "Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789044.
All > Peripheral Neuropathy
~12 spots leftby Oct 2024
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