Status:
UNKNOWN
Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
Lead Sponsor:
WellSpan Health
Collaborating Sponsors:
Neuraptive Therapeutics Inc.
Conditions:
Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
Eligibility:
All Genders
16-65 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.
Detailed Description
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much rese...
Eligibility Criteria
Inclusion
- Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
- Class III nerve injury (Sunderland's 4th or 5th degree injury)
- Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
- Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
- Injuries beyond 24 hours will be excluded
Exclusion
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03236064
Start Date
May 1 2016
End Date
May 1 2024
Last Update
January 26 2021
Active Locations (1)
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1
WellSpanYork Hospital
York, Pennsylvania, United States, 17405