Peripheral Nerve Injuries Clinical Trial
Official title:
Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to SOC in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring Below the Distal Border of the Brachial Plexus Requiring Surgical Repair.
NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.
NTX-001 (Product) is a surgical product that consists of an active solution (drug), an isolation chamber medical device (chamber or device) and two (2) other sterile solutions. NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03999424 -
Autologous Human Schwann Cells in Peripheral Nerve Repair
|
Phase 1 | |
| Not yet recruiting |
NCT05848778 -
Non-invasive Therapy to Drive Nerve Regeneration
|
N/A | |
| Completed |
NCT02070367 -
Somatosensory Assessment and Rehabilitation of Allodynia (SARA)
|
N/A | |
| Recruiting |
NCT03205124 -
The Effect of Pre-operative Electrical Stimulation on Peripheral Nerve Regeneration.
|
Phase 2/Phase 3 | |
| Recruiting |
NCT01526681 -
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction
|
||
| Recruiting |
NCT03422107 -
Somatosensory Evoked Potential (SSEP) Monitoring for Detection of Intraoperative Positional Neuropraxia
|
N/A | |
| Active, not recruiting |
NCT05339594 -
REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
|
||
| Completed |
NCT02437695 -
Robot Assisted Radical Prostatecomy and Positional Injury
|
N/A | |
| Completed |
NCT02786888 -
Prospective Comparison of Adductor Canal Block Performed With a Multiport Versus Single Bevel Needle
|
N/A | |
| Completed |
NCT01954199 -
The Effectiveness of Neurodynamic Techniques in Patients With Nerve-Related Leg Pain
|
N/A | |
| Withdrawn |
NCT02095899 -
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome
|
Phase 2 | |
| Recruiting |
NCT02403661 -
Electrical Stimulation to Enhance Peripheral Nerve Regeneration
|
N/A | |
| Completed |
NCT03191032 -
Early Sensory Re-education of the Hand With a Sensor Glove Model
|
N/A | |
| Recruiting |
NCT06209801 -
Mirror Therapy Integrated With Electrical Stimulation for Cortical Modulations
|
N/A | |
| Recruiting |
NCT03913689 -
StimRouter Registry Clinical Protocol
|
||
| Terminated |
NCT02459015 -
Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions
|
N/A | |
| Recruiting |
NCT03780855 -
Preliminary Evaluation of the Clinical Safety and Effectiveness of the Bionic Nerve Scaffold
|
N/A | |
| Recruiting |
NCT05884125 -
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
|
N/A | |
| Recruiting |
NCT04789044 -
Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)
|
Phase 2 | |
| Recruiting |
NCT05611983 -
Experience and Feasibility of Methods for Early Sensory Training
|
N/A |