NeuromaNCT02528266
Surgical Treatment of Symptomatic Neuroma "Stop Neuroma"
A study testing Nerve Capping Device in people with Neuroma, run by Polyganics BV at 7 sites in 2 countries.
Trial summary
This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroma
- What is being tested?
- Nerve Capping Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2016to 30 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible according to the following criteria:
- Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- Subjects who are > 18 years year old.
- Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
- Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
- Symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as any reduction in VAS questionnaire score.
- Subjects with history of pain in the area of the end-neuroma for at least 6-months.
- Subjects with a positive Tinel's sign.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participation:
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
- Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control.
- Subjects who have had historical radiotherapy in the area of the end-neuroma.
- Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
- Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
Show all 11Show fewer
- Subjects is involved in another pain study.
- Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
- Subjects with a symptomatic neuroma that underwent surgical treatment for pain management on two or more occasions.
- Insufficient soft tissue at the end-neuroma site to cover the investigational device.
- Immunosuppressed patients, or patients with planned immunosuppressive therapy within 12-month following the study procedure.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Netherlands6 sites
Albert Schweitzer Hospital
Dordrecht, 3318 AT
UMCG
Groningen, 9713GZ
Martini Hospital Groningen
Groningen, 9728 NT
MC Groep
Lelystad, 8233AA
MUMC
Maastricht, 6229 HX
Haga Hospital
The Hague, 2545 CH
About this study
Official title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.
- Conditions
- Neuroma
- Being tested
- Nerve Capping Device
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Capping DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Nerve Capping Device | Experimental | Implant with the experimental device Receives: Device: Nerve Capping Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety data (Serious adverse events )
Serious adverse events related to the investigation device as determine by independent expert.
Measured: 6 weeks
Effectiveness (VAS score)
Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) at 6-week follow-up compared to score at baseline.
Measured: 6 weeks
Effectiveness (QuickDASH score)
Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) at 6-week follow-up compared to score at baseline.
Measured: 6 weeks
Effectiveness (Quantity and class of pain medication used)
Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline
Measured: 6 weeks
Secondary outcomes (7)
Safety (Rate of serious adverse device effects)
Rate of serious adverse device effects as determined by the physician and independent expert.
- Reduction of pain caused by symptomatic neuroma after 3 months, 6 months and 12 months following the procedure, as compared to pain before the procedure.
- Improvement of quality of life at 3 months, 6 months and 12 months follow-up, as compared to the quality of life before the procedure.
- ≤20% recurrence of symptomatic neuroma within 12 months.
- Reduction of pain medication used to treat neuroma pain at 3 months, 6 months and 12 months, as compared to the quantity pain medication used for the neuroma pain before the procedure.
Measured: 3, 6 and 12 months
Effectiveness (VAS score)
Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) compared to score at baseline.
Measured: 3, 6, 12 months
Effectiveness (QuickDASH score)
Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) compared to score at baseline.
Measured: 3, 6, 12 months
Effectiveness (DN4 score)
Pain caused by symptomatic end-neuroma: DN4 score (10 y/n items characterising pain) compared to score at baseline.
Measured: 6 weeks, 3, 6, 12 months
Effectiveness (Elliot score)
Pain caused by symptomatic end-neuroma: Elliot score (5 items rated 0 (no pain) to 4 (pain intolerable)) compared to score at baseline.
Measured: 6 weeks, 3, 6, 12 months
Effectiveness (Quantity and class of pain medication used)
Quantity and class of pain medication used for the neuroma pain at 3, 6 and 12 months
Measured: 3, 6, 12 months
Rate of recurrence of symptomatic neuroma
defined as daily pain combined with increased used of pain medication compared to baseline and no improvement in QuickDASH score, but pain is relieved with Xylocaine nerve block.
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 posted19 Aug 2015 (estimated)
- Study startJan 2016
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyganics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Betty IJmker, MSc, Study chair, Polyganics BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528266
- Sponsor's protocol ID
- 034A01_CIP
- Status last verified
- Jun 2018
- First submitted
- 13 Aug 2015
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section
- ClinicalTrials.gov ID
- NCT02528266
- Acronym / sponsor ID
- 034A01_CIP
- Conditions
- Neuroma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Polyganics BVIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 19 Aug 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.
This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Capping Device | Experimental | Device: Nerve Capping DeviceImplant with the experimental device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- Subjects who are > 18 years year old.
- Subjects with a diagnosis of symptomatic primary or secondary end-neuroma.
- Symptomatic neuroma located on the upper limb between the metacarpophalangeal (MCP) joints to shoulder.
- Symptomatic neuroma confirmed by pain relief following a 10min ±2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as any reduction in VAS questionnaire score.
Key exclusion criteria (11 listed)
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements.
- Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation or subjects who are not using appropriate birth control.
- Subjects who have had historical radiotherapy in the area of the end-neuroma.
- Symptomatic neuroma located proximally from the shoulder or distally from MCP joints.
- Subjects not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone).
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 |
|---|---|---|
| Nerve Capping Device | Device | Nerve Capping Device |
Primary outcome
Safety data (Serious adverse events )
Time frame: 6 weeks
Serious adverse events related to the investigation device as determine by independent expert.
Effectiveness (VAS score)
Time frame: 6 weeks
Pain caused by symptomatic end-neuroma: VAS score (0-100 / no pain - unbearable pain) at 6-week follow-up compared to score at baseline.
Effectiveness (QuickDASH score)
Time frame: 6 weeks
Pain caused by symptomatic end-neuroma: QuickDASH score (30 items scored 1-5) at 6-week follow-up compared to score at baseline.
Effectiveness (Quantity and class of pain medication used)
Time frame: 6 weeks
Quantity and class of pain medication used for the end-neuroma pain at 6-week follow-up compared to baseline
7 secondary outcomes
Safety (Rate of serious adverse device effects)
Time frame: 3, 6 and 12 months
Effectiveness (VAS score)
Time frame: 3, 6, 12 months
Effectiveness (QuickDASH score)
Time frame: 3, 6, 12 months
Effectiveness (DN4 score)
Time frame: 6 weeks, 3, 6, 12 months
Effectiveness (Elliot score)
Time frame: 6 weeks, 3, 6, 12 months
Effectiveness (Quantity and class of pain medication used)
Time frame: 3, 6, 12 months
Rate of recurrence of symptomatic neuroma
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 13 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Neuroma
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Not yet recruitingPhase 2
Selumetinib for NF2-Related Schwannomatosis
Neurofibromatosis Type 2, NF2
RecruitingPhase 2
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
Neurofibromatosis Type 2, Vestibular Schwannoma
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
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.
Betty IJmker, MSc study chair
Polyganics BV
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Capping Device in people with Neuroma, run by Polyganics BV at 7 sites in 2 countries.
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 8 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 13 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 7 sites in Netherlands, France. 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?
Safety data (Serious adverse events ) (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 13 Jun 2018.