Peripheral Nerve InjuriesNCT02459015
Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions
A study testing Implantation in people with Peripheral Nerve Injuries, run by Medovent GmbH at 4 sites in Germany.
Trial summary
The purpose of this clinical investigation is to confirm the medium- and long-term safety and performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an autologous nerve graft to bridge nerve defects in the finger. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesGermany
- Study dates
- Jun 2015to 31 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females between 18 and 65 years of age able to give his/her consent
- a complete traumatic nerve injury of the common or proper digital nerve in the hand
- a nerve defect of less or equal than 26 mm after release and approximation of the nerve ends and measured when the wrist is in neutral position
- an injury that could conventionally be treated with implantation of a short nerve graft
- nerve treatment initiated until 3 months after nerve injury
- signed informed consent
Who cannot join
- known allergy to chitosan and/or polyvinylpyrrolidone (PVP)
- known impairment / previous diseases of the neural axis or previous lesions of the affected hand (of the digital nerve), which led to permanent sensory or motor restrictions of the hand/finger
- complete amputation injury
- known pregnant or breast-feeding females
- disorders known leading to impaired wound healing (e.g. diabetes mellitus)
- skin diseases in the wound area
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- impaired blood coagulation or bleeding disorders (e.g. because of regular intake of cumarin such as Marcumar)
- pathologic blood flow disorders (e.g. Morbus Raynaud)
- participated in another clinical investigation using an investigational new drug or device within 30 days prior to enrolment into this investigation
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Unfallkrankenhaus Berlin
Berlin, 12683
BG-Kliniken Bergmannstrost
Halle, Saxony-Anhalt, 06112
BG Kliniken Hamburg gGmbH
Hamburg, 21033
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: A Controlled, Randomized, Comparison, Blind Evaluation of Repair of Digital Nerve Lesions in Man Using an Implanted Reaxon® Nerve Guide
The purpose of this clinical investigation is to confirm the medium- and long-term safety and performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an autologous nerve graft to bridge nerve defects in the finger.
Read the detailed description
The clinical investigation NG-001 is a multicenter, parallel, controlled, randomized, blind evaluation of the repair of digital nerve lesions.
Medovent will perform this clinical investigation as a post-market clinical follow-up (PMCF) study in accordance with the MEDDEV 2.12/2 rev2 guidelines to confirm the medium- and long-term safety and performance of its chitosan-based nerve guide (Reaxon® Nerve Guide). The results of this investigation will be used by Medovent to update the clinical evaluation throughout the life-cycle of Reaxon® Nerve Guide and to ensure its long term safety and performance in the market. Additionally, Medovent will include the application of Reaxon® Nerve Guide in digital nerves to confirm the safety of applying Reaxon® Nerve Guide over joints.
The study will be performed in specialized German centers. A total number of 76 subjects with traumatic digital nerve injuries in whom surgical repair may not allow end-to-end direct suture of the nerve ends, and in whom the nerve tissue gap would indicate the use of an autograft of equal or less than 26 mm, are eligible for inclusion.
The primary objective of the clinical investigation is to demonstrate that the static 2-point discrimination (2-PD) 12 months after surgery will be not inferior in the Reaxon® Nerve Guide test group compared to the control group receiving an autologous nerve graft.
The secondary objective is to document the long-term effects (up to 18 months after surgery) in nerve repair. The non-inferiority test is to demonstrate that it can be excluded that the treatment difference is larger than 20% in favor for the control group.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Implantation
- 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.
ImplantationDevice
A peripheral nerve defect up to 26 mm in the finger will be repaired by implantation of either a Reaxon® Nerve Guide or an autologous nerve graft (depending on the randomization group) on day 0.
| Study group | Role | What they receive |
|---|---|---|
| Reaxon® Nerve Guide | Experimental | Implantation of Reaxon® Nerve Guide: If the subject is randomized to the Reaxon® Nerve Guide group, the surgeon will implant a Reaxon® Nerve Guide of ≤ 30 mm to bridge a nerve defect of ≤ 26 mm according to the method described in the instructions for use. Receives: Device: Implantation |
| Autologous Nerve Graft | Active comparator | Implantation of an autologous nerve graft: If the subject is randomized to the conventional treatment, the surgeon will repair the nerve by interposing an autologous nerve graft of ≤ 26 mm between the nerve ends. Receives: Device: Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static 2-point discrimination (2-PD)
The perception of either one or two points of touch is assessed using a small tool with prongs at fixed spacing's from 2 to 15 mm. One or two points will be applied randomly in a longitudinal direction on the distal phalanx of all fingers.
Grades/scores:
0 = > 15 mm (poor)
- = 11-15 mm (fair)
- = 6-10 mm (good)
- = < 6 mm (excellent)
Scores of 2 or 3 will be evaluated as (meaningful) response. At a score of 0 it will further be determined if the subject has protective sensibility or is anesthetic. A disposable cannula can be used.
Single point is noticeable = protective sensibility No point is noticeable = anesthetic
Measured: Primary outcome analysis will be performed from the clinical evaluations at 12 months post-surgery
Secondary outcomes (6)
Static 2-point discrimination (2-PD)
see description above
Measured: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Moving 2-PD
A moving stimulus of either one or two points is assessed using a small tool with prongs at fixed spacing's from 2 to 15 mm. One or two points will be moved randomly in a longitudinal direction from proximal to distal of all fingers.
Grades/scores: see Static 2-PD
Measured: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Semmes-Weinstein Monofilament
The 5 kit monofilaments will be used. A monofilament is pressed against the skin at specific locations (see protocol) starting with the thinnest filament (i.e. 2.83) and then, depending on the response, thicker filaments are applied until the subject feels the pressure.
Grades/scores:
0 = not testable
- = filament 6.65, perception of deep pressure
- = filament 4.56, no protective sensation
- = filament 4.31, diminished protective sensation
- = filament 3.61, diminished perception of light touch
- = filament 2.83, normal perception of light touch
Measured: Follow-up examinations 3, 6, 12 and 18 months post-surgery
Subject's estimation of cold intolerance and hyperesthesia
The examiner will stroke the dysfuntional area and question the subject about cold intolerance and hypersensitivity.
Grades/scores:
0 = Hinders function
- = Disturbing
- = Moderate
- = None/minor
Measured: Follow-up examinations 3, 6, 12 and 18 months post-surgery
Hoffmann-Tinel-Test
The test is performed by lightly tapping over the nerve to elicit a sensation of tingling in the distribution of the nerve. The distance of the sensation from the distal end of the implant will be determined.
Measured: Follow-up examinations 3, 6, 12 and 18 months post-surgery
post-operative complications
There will be evaluations of common post-operative complications associated with peripheral nerve repair surgery, i.e. painful neuroma formation, assessed by pain on percussion, allodynia, and dysaesthesia (pain and/or numbness).
Measured: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion31 May 2018
- Study completion31 May 2018
Why it stopped: The study was stopped due to slow patient recruitment and insufficient patient compliance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medovent GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Siemers, PD Dr. med., Principal investigator, BG-Kliniken Bergmannstrost
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459015
- Sponsor's protocol ID
- NG-001
- Status last verified
- Jun 2018
- First submitted
- 28 May 2015
- Last updated
- 18 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Comparison, Blind Evaluation of Repair of Digital Nerve Lesions in Man Using an Implanted Reaxon® Nerve Guide
- ClinicalTrials.gov ID
- NCT02459015
- Acronym / sponsor ID
- NG-001
- Conditions
- Peripheral Nerve Injuries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to slow patient recruitment and insufficient patient compliance.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medovent GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 1 Jun 2015 (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.
The purpose of this clinical investigation is to confirm the medium- and long-term safety and performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an autologous nerve graft to bridge nerve defects in the finger.
Detailed description
The clinical investigation NG-001 is a multicenter, parallel, controlled, randomized, blind evaluation of the repair of digital nerve lesions.
Medovent will perform this clinical investigation as a post-market clinical follow-up (PMCF) study in accordance with the MEDDEV 2.12/2 rev2 guidelines to confirm the medium- and long-term safety and performance of its chitosan-based nerve guide (Reaxon® Nerve Guide). The results of this investigation will be used by Medovent to update the clinical evaluation throughout the life-cycle of Reaxon® Nerve Guide and to ensure its long term safety and performance in the market. Additionally, Medovent will include the application of Reaxon® Nerve Guide in digital nerves to confirm the safety of applying Reaxon® Nerve Guide over joints.
The study will be performed in specialized German centers. A total number of 76 subjects with traumatic digital nerve injuries in whom surgical repair may not allow end-to-end direct suture of the nerve ends, and in whom the nerve tissue gap would indicate the use of an autograft of equal or less than 26 mm, are eligible for inclusion.
The primary objective of the clinical investigation is to demonstrate that the static 2-point discrimination (2-PD) 12 months after surgery will be not inferior in the Reaxon® Nerve Guide test group compared to the control group receiving an autologous nerve graft.
The secondary objective is to document the long-term effects (up to 18 months after surgery) in nerve repair. The non-inferiority test is to demonstrate that it can be excluded that the treatment difference is larger than 20% in favor for the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reaxon® Nerve Guide | Experimental | Device: ImplantationImplantation of Reaxon® Nerve Guide: If the subject is randomized to the Reaxon® Nerve Guide group, the surgeon will implant a Reaxon® Nerve Guide of ≤ 30 mm to bridge a nerve defect of ≤ 26 mm according to the method described in the instructions for use. |
| Autologous Nerve Graft | Active comparator | Device: ImplantationImplantation of an autologous nerve graft: If the subject is randomized to the conventional treatment, the surgeon will repair the nerve by interposing an autologous nerve graft of ≤ 26 mm between the nerve ends. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males and females between 18 and 65 years of age able to give his/her consent
- a complete traumatic nerve injury of the common or proper digital nerve in the hand
- a nerve defect of less or equal than 26 mm after release and approximation of the nerve ends and measured when the wrist is in neutral position
- an injury that could conventionally be treated with implantation of a short nerve graft
- nerve treatment initiated until 3 months after nerve injury
Key exclusion criteria (9 listed)
- known allergy to chitosan and/or polyvinylpyrrolidone (PVP)
- known impairment / previous diseases of the neural axis or previous lesions of the affected hand (of the digital nerve), which led to permanent sensory or motor restrictions of the hand/finger
- complete amputation injury
- known pregnant or breast-feeding females
- disorders known leading to impaired wound healing (e.g. diabetes mellitus)
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 |
|---|---|---|
| ImplantationA peripheral nerve defect up to 26 mm in the finger will be repaired by implantation of either a Reaxon® Nerve Guide or an autologous nerve graft (depending on the randomization group) on day 0. | Device | Autologous Nerve Graft, Reaxon® Nerve Guide |
Primary outcome
Static 2-point discrimination (2-PD)
Time frame: Primary outcome analysis will be performed from the clinical evaluations at 12 months post-surgery
The perception of either one or two points of touch is assessed using a small tool with prongs at fixed spacing's from 2 to 15 mm. One or two points will be applied randomly in a longitudinal direction on the distal phalanx of all fingers. Grades/scores: 0 = > 15 mm (poor) 1. = 11-15 mm (fair) 2. = 6-10 mm (good) 3. = < 6 mm (excellent) Scores of 2 or 3 will be evaluated as (meaningful) response. At a score of 0 it will further be determined if the subject has protective sensibility or is anesthetic. A disposable cannula can be used. Single point is noticeable = protective sensibility No point is noticeable = anesthetic
6 secondary outcomes
Static 2-point discrimination (2-PD)
Time frame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Moving 2-PD
Time frame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Semmes-Weinstein Monofilament
Time frame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
Subject's estimation of cold intolerance and hyperesthesia
Time frame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
Hoffmann-Tinel-Test
Time frame: Follow-up examinations 3, 6, 12 and 18 months post-surgery
post-operative complications
Time frame: Baseline visit (latest 7 days post-surgery) + Follow-up examinations 3, 6, 12 and 18 months post-surgery
Results and safety
The study was stopped early (reason given: The study was stopped due to slow patient recruitment and insufficient patient compliance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
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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.
Frank Siemers, PD Dr. med. principal investigator
BG-Kliniken Bergmannstrost
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation in people with Peripheral Nerve Injuries, run by Medovent GmbH at 4 sites in Germany.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 was stopped early (reason given: The study was stopped due to slow patient recruitment and insufficient patient compliance.). Results are not available in the source record.
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?
Static 2-point discrimination (2-PD) (time frame: Primary outcome analysis will be performed from the clinical evaluations at 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2018; AzTrials last refreshed its copy on 31 Oct 2026.