A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury (UMANC)
Primary Purpose
Injury of Nerves at Wrist and Hand Level
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Polynerve
Sponsored by
About this trial
This is an interventional treatment trial for Injury of Nerves at Wrist and Hand Level focused on measuring Nerve regeneration, Peripheral nerve injury, Nerve conduits, Sensory nerve transection
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any trial specific procedures
- Traumatic injury/injuries to the hand with clinical suspicion of sensory nerve transection mandating surgical exploration
- Male and females aged 18-80
Exclusion Criteria:
- Concomitant injuries requiring surgical treatment from other specialists
- Specified co-morbidities that would increase a participants risk of infection including diabetes, renal/liver disease, autoimmune diseases, primary or secondary immunocompromised participants (including immunosuppressive drugs or known disease resulting in suppressed immunity)
- A stated hypersensitivity or allergy to the polymers PCL/PLA
- Any other significant co-morbidity impacting on the risk of surgery (to be determined by the multi-disciplinary team (MDT))
- Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days.
Sites / Locations
- Wythenshawe Hospital, Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Polynerve
Arm Description
Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.
Outcomes
Primary Outcome Measures
Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications
To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand
Secondary Outcome Measures
Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia
To measure efficacy of the polymer biomaterial nerve conduit to support nerve regeneration following the transection of the sensory nerve of the hand
Full Information
NCT ID
NCT02970864
First Posted
November 15, 2016
Last Updated
October 31, 2022
Sponsor
University of Manchester
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02970864
Brief Title
A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury
Acronym
UMANC
Official Title
A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
May 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Participants with a traumatic sensory nerve injury in the hand will be recruited to the study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve. Participants will be followed up regularly, observed for device-related complications and to assess the return of sensory innervation.
Detailed Description
Peripheral nerve injuries are a common occurrence, with approximately 9000 cases in the United Kingdom (UK) occurring each year. Most are in a predominantly young and working population. Where surgical reconstruction is required to repair the peripheral nerve injury, techniques employed have changed little in the last 50-60 years with many factors influencing the outcomes, such as age of patient, timing, level and extent of injury, method of repair and the surgeon's skill .
Despite advances in microsurgical nerve repair techniques, functional recovery is often poor e.g. resulting impaired hand sensation, reduced motor function and frequent pain and cold intolerance. This can have a profound and permanent impact on the patient's recovery and subsequent quality of life. Nerve repair has significant health, social and cost implications with the treatment and rehabilitation of an employed person, estimated to be EUR 51,238.
Peripheral nerve injury usually presents with nerve stumps that can be approximated in surgical repair: direct, end-to-end suture repair of the epineurium (neurorrhaphy). Excessive tension over the suture line leads to poor results; therefore when the nerve stumps cannot be approximated without tension, an alternative surgical method is required.
Where the nerve gap exceeds more than 5 mm, there are two fundamental options, either 'nerve grafting' or 'tubulisation' using a bridging material. This trial will examine the first-in-man use of a new nerve conduit device 'Polynerve' to repair small nerve gaps in digital sensory nerves of the hand. Polynerve is a degradable co-polymer of Poly ε-caprolactone (PCL) and Poly (L-lactic acid) (PLA) which is shaped as a cylinder with a novel internal lumen consisting of a specific micro-grooved architecture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Nerves at Wrist and Hand Level
Keywords
Nerve regeneration, Peripheral nerve injury, Nerve conduits, Sensory nerve transection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polynerve
Arm Type
Experimental
Arm Description
Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.
Intervention Type
Device
Intervention Name(s)
Polynerve
Intervention Description
Polymer biomaterial nerve conduit
Primary Outcome Measure Information:
Title
Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications
Description
To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia
Description
To measure efficacy of the polymer biomaterial nerve conduit to support nerve regeneration following the transection of the sensory nerve of the hand
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any trial specific procedures
Traumatic injury/injuries to the hand with clinical suspicion of sensory nerve transection mandating surgical exploration
Male and females aged 18-80
Exclusion Criteria:
Concomitant injuries requiring surgical treatment from other specialists
Specified co-morbidities that would increase a participants risk of infection including diabetes, renal/liver disease, autoimmune diseases, primary or secondary immunocompromised participants (including immunosuppressive drugs or known disease resulting in suppressed immunity)
A stated hypersensitivity or allergy to the polymers PCL/PLA
Any other significant co-morbidity impacting on the risk of surgery (to be determined by the multi-disciplinary team (MDT))
Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Reid
Organizational Affiliation
University of Manchester
Official's Role
Study Chair
Facility Information:
Facility Name
Wythenshawe Hospital, Manchester University NHS Foundation Trust
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32685131
Citation
Murphy R, Faroni A, Wong J, Reid A. Protocol for a phase I trial of a novel synthetic polymer nerve conduit 'Polynerve' in participants with sensory digital nerve injury (UMANC). F1000Res. 2019 Jun 24;8:959. doi: 10.12688/f1000research.19497.1. eCollection 2019.
Results Reference
derived
Learn more about this trial
A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury
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