Injury of Nerves at Wrist and Hand LevelUMANCNCT02970864
A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury
A study testing Polynerve in people with Injury of Nerves at Wrist and Hand Level, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Injury of Nerves at Wrist and Hand Level
- What is being tested?
- Polynerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Aug 2017to 6 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wythenshawe Hospital, Manchester University NHS Foundation Trust
Wythenshawe, Manchester, M23 9LT
About this study
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.
Read the 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.
- Conditions
- Injury of Nerves at Wrist and Hand Level
- Being tested
- Polynerve
- Keywords
- Nerve regeneration, Peripheral nerve injury, Nerve conduits, Sensory nerve transection
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolynerveDevice
Polymer biomaterial nerve conduit
| Study group | Role | What they receive |
|---|---|---|
| Polynerve | Experimental | Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve. Receives: Device: Polynerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start17 Aug 2017
- Primary completion31 Aug 2019
- Study completion6 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Nerves at Wrist and Hand LevelStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Adam Reid, University of Manchester
- Investigators
- Adam Reid, Study chair, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970864
- Sponsor's protocol ID
- R116863
- Other IDs
- 2016-001667-37, 2016
- Acronym
- UMANC
- Status last verified
- Oct 2022
- First submitted
- 15 Nov 2016
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32685131
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury
- ClinicalTrials.gov ID
- NCT02970864
- Acronym / sponsor ID
- UMANC / R116863
- Conditions
- Injury of Nerves at Wrist and Hand Level
- Keywords
- Nerve regeneration, Peripheral nerve injury, Nerve conduits, Sensory nerve transection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 6 May 2021 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polynerve | Experimental | Device: PolynerveParticipants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolynervePolymer biomaterial nerve conduit | Device | Polynerve |
Primary outcome
Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications
Time frame: 1 year
To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand
1 secondary outcome
Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 32685131Murphy 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Reid study chair
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polynerve in people with Injury of Nerves at Wrist and Hand Level, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02970864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.