Trials Sponsors Conditions Drugs Pricing

Conditions

Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter

Outcome Measures

Primary Outcomes (1)

To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure
12 months

Study Arms (1)

Nerve injury to palm and fingers

EXPERIMENTAL

Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited

Drug: Polyethylene Glycols

Interventions

Polyethylene GlycolsDrug

Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques

Nerve injury to palm and fingers

Eligibility Criteria

Age16 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Neuraptive Therapeutics Inc.
Industrycollaborator
WellSpan Health
Otherlead

Study Sites (1)

WellSpanYork Hospital

York, Pennsylvania, 17405, United States

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

Richard C Trevino, MD
WellSpan York Hospital
PRINCIPAL INVESTIGATOR

Enrollment

4 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

August 1, 2017

Study Start

May 2016

Actual (reported)

Primary Completion

Study Stopped

Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Nerve injury to palm and fingers

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Nerve injury to palm and fingers

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations