Patients With a Scheduled (Diagnostic) Nervus Suralis BiopsyPeRepairNCT01884376
Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix
A study testing Neuromaix in people with Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy
- What is being tested?
- Neuromaix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to May 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both genders in the age between 18 und 70 years
- patients who are scheduled for a nerve biopsy
Who cannot join
- alcohol-related polyneuropathy
- paraneoplastic polyneuropathy
- present: immunosuppressive therapy
- present: malignant tumor
- peripheral vascular diseases
- collagen diseases (e.g. existing keloid scars)
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- patients with an increased wound healing disorder (e.g. diabetics)
- patients with chronic venous insufficiency (vein thrombosis, skin diseases)
- patients with coagulation and bleeding disorders (ASA- or Marcumar-patients)
- present: pregnancy
- HIV, Hepatitis B or Hepatitis C infection
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen
Aachen, 52074
About this study
Official title: Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix
The aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device.
Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap.
Read the detailed description
The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing regenerating axons to grow through the scaffold, into the distal nerve tissue towards the target muscle or skin.
Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the regenerating axons while bridging the nerve gap.
- Being tested
- Neuromaix
- Keywords
- nerve biopsy, nerve regeneration, neuroma pain, loss of sensation
- Medical subject headings
- Disease, Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromaixDevice
| Study group | Role | What they receive |
|---|---|---|
| Neuromaix implantation | Experimental | Implantation of Neuromaix during an diagnostic nerve biopsy Receives: Device: Neuromaix |
What is being measured
The primary outcome is the main question the study is designed to answer.
proof of safety of the medical device Neuromaix
The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications
Measured: 12 months
Secondary outcomes (1)
effectiveness evaluation of the implant device Neuromaix
The secondary objective is the evaluation of the effectiveness of the Neuromaix implantation ("Performance arm of study").
key parameters: axonal regeneration and recovery of sensory function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With a Scheduled (Diagnostic) Nervus Suralis BiopsyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmet Bozkurt, PD Dr. med., Principal investigator, Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884376
- Sponsor's protocol ID
- 10-009
- Acronym
- PeRepair
- Status last verified
- Jun 2015
- First submitted
- 19 Jun 2013
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix
- ClinicalTrials.gov ID
- NCT01884376
- Acronym / sponsor ID
- PeRepair / 10-009
- Keywords
- nerve biopsy, nerve regeneration, neuroma pain, loss of sensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jun 2013 (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 aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device.
Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap.
Detailed description
The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing regenerating axons to grow through the scaffold, into the distal nerve tissue towards the target muscle or skin.
Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the regenerating axons while bridging the nerve gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromaix implantation | Experimental | Device: NeuromaixImplantation of Neuromaix during an diagnostic nerve biopsy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- both genders in the age between 18 und 70 years
- patients who are scheduled for a nerve biopsy
Key exclusion criteria (11 listed)
- alcohol-related polyneuropathy
- paraneoplastic polyneuropathy
- present: immunosuppressive therapy
- present: malignant tumor
- peripheral vascular diseases
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 |
|---|---|---|
| Neuromaix | Device | Neuromaix implantation |
Primary outcome
proof of safety of the medical device Neuromaix
Time frame: 12 months
The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications
1 secondary outcome
effectiveness evaluation of the implant device Neuromaix
Time frame: 12 months
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 18 Jun 2015.
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.
Ahmet Bozkurt, PD Dr. med. principal investigator
Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromaix in people with Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy, run by RWTH Aachen University at 1 site 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 2 inclusion and 11 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 18 Jun 2015. 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 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 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?
proof of safety of the medical device Neuromaix (time frame: 12 months). 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 2015.