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Tests treatment safety and results for Peripheral Nerve Injuries
Official title Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
ClinicalTrials.gov ID: NCT04789044
What this study is testing
What is NTX-001?
NTX-001 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for peripheral nerve injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Ages 18-80
- Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
- Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury...
- 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...
You likely can't join if
- Patients beginning surgery within hours after injury.
- Injury to the brachial plexus nerves
- Injury to the nerves distal to the distal flexion crease of the wrist
- Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous...
- Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
- Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
See the full eligibility criteria
- Ages 18-80
- Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
- 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...
- 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).
- Patients beginning surgery within hours after injury.
- Injury to the brachial plexus nerves
- Injury to the nerves distal to the distal flexion crease of the wrist
- 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...
- Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
- Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
- 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).
- Not expected to survive the next 30 days due to their injuries/health condition.
- The subject has a known allergy to polyethylene glycol (PEG).
- 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.
- The subject is pregnant and/or is breastfeeding.
- The subject has a significant medical comorbidity precluding immediate repair.
- The subject is not able to strictly adhere to the rules of the current clinical protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Camden, New Jersey, United States
- Charlotte, North Carolina, United States
- York, Pennsylvania, United States
- San Antonio, Texas, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Camden, New Jersey, United States; Charlotte, North Carolina, United States; York, Pennsylvania, United States; San Antonio, Texas, United States; Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.