At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
NTX-001combination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating NTX-001 for Peripheral Nerve Injuries. Completed, enrolled 51 participants across 10 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Nerve Injuries
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedOct 2020
Primary CompletionJun 2024
TodayJul 2026
First PostedOct 1, 2020
Enrollment StartSep 25, 2020
Primary CompletionJun 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 5.8 years ago
Interventions
NTX-001combination
One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.