NeuromaNCT02993276
Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
An observational study of Neuroma, run by Polyganics BV at 16 sites in 7 countries.
Trial summary
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro) This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroma
- What is being tested?
- Neurocap®
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 17 Apr 2017to 30 Aug 2020
- Phase
- Observational
- 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
Study population: Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.
Who may be able to join
- Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- Subjects who are able to comply with the follow-up or other requirements.
- Subjects who are ≥ 18 years old.
- Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
- Subjects with a positive Tinel's sign.
- Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS questionnaire score.
- Subjects that are indicated for surgery to treat symptomatic neuroma.
Who cannot join
- Subjects who do not complete the informed consent.
- Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
- Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
- Subjects with congenital neuropathy.
- Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.
- Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
Show all 9Show fewer
- Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).
- Proximal nerve end > 8mm.
- Pregnancy.
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
United States8 sites
Geisinger Clinic
Danville, Pennsylvania, 17822
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6061
The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)
Philadelphia, Pennsylvania, 19107
Arizona Center for Hand Surgery
Phoenix, Arizona, 85004
Veterans affairs Medical Center Portland
Portland, Oregon, 97239
Stanford Medical Center Hand and Upper Limb Center
Redwood City, California, 94063
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
Buncke Clinic
San Francisco, California, 94114
Sweden3 sites
Sahlgrenska University Hospital Gothenburg
Gothenburg
University Hospital Linköping
Linköping
University Hospital Lund - Department of Hand Surgery
Malmö
Germany1 site
BG Trauma Center Frankfurt am Main GmbH
Frankfurt am Main, 60389
About this study
Official title: Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)
This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
Read the detailed description
- Device description NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
- Objective This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
- Study design This post-market surveillance study consists of a cohort study to provide post market surveillance information regarding long-term performance and ease of use of the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in the upper and lower extremity. Sub analyses will be performed regarding demographics and medical background.
- Conditions
- Neuroma
- Being tested
- Neurocap®
- Medical subject headings
- Neuroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocap®Device
NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma. Receives: Device: Neurocap® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Pain
Subjective pain score as indicated by the patient on a scale of 1-100.
Measured: 2 years
Secondary outcomes (6)
Recurrence of Neuroma
Recurrence of neuroma as assessed by clinical assessment by the surgeon.
Measured: 2 years
Elliot Neuroma questionnaire
Type of pain
Measured: 2 years
QuickDASH
Daily functioning upper limb
Measured: 2 years
Goals questionnaire
Daily functioning lower limb
Measured: 2 years
Type of Pain Medication
Type of pain medication currently taken
Measured: 2 years
Amount of Pain Medication
Amount of pain medication currently taken
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start17 Apr 2017
- Primary completion6 Jul 2018
- Study completion30 Aug 2020
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyganics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993276
- Sponsor's protocol ID
- CR-02
- Status last verified
- Sep 2019
- First submitted
- 8 Dec 2016
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Power D, Curtin C, Bellemere P, Nyman E, Pajardi G, Isaacs J, Levin LS. Surgical Treatment of Symptomatic End-Neuroma With a New Bioresorbable Copolyester Nerve Capping Device: A Multicenter Prospective Cohort Study. Ann Plast Surg. 2023 Jul 1;91(1):109-116. doi: 10.1097/SAP.0000000000003596.
PubMed 37450869
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma
- ClinicalTrials.gov ID
- NCT02993276
- Acronym / sponsor ID
- CR-02
- Conditions
- Neuroma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Polyganics BVIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 15 Dec 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.
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)
This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
Detailed description
- Device description NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone) (PLCL).
- Objective This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
- Study design This post-market surveillance study consists of a cohort study to provide post market surveillance information regarding long-term performance and ease of use of the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in the upper and lower extremity. Sub analyses will be performed regarding demographics and medical background.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: Neurocap®All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the neuroma.
Key inclusion criteria (7 listed)
- Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
- Subjects who are able to comply with the follow-up or other requirements.
- Subjects who are ≥ 18 years old.
- Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
- Subjects with a positive Tinel's sign.
Key exclusion criteria (9 listed)
- Subjects who do not complete the informed consent.
- Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
- Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
- Subjects with congenital neuropathy.
- Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.
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 |
|---|---|---|
| Neurocap®NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma. | Device | Treatment Group |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: 2 years
Subjective pain score as indicated by the patient on a scale of 1-100.
6 secondary outcomes
Recurrence of Neuroma
Time frame: 2 years
Elliot Neuroma questionnaire
Time frame: 2 years
QuickDASH
Time frame: 2 years
Goals questionnaire
Time frame: 2 years
Type of Pain Medication
Time frame: 2 years
Amount of Pain Medication
Time frame: 2 years
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 10 Sep 2020.
- Derived from this study: PubMed 37450869Power D, Curtin C, Bellemere P, Nyman E, Pajardi G, Isaacs J, Levin LS. Surgical Treatment of Symptomatic End-Neuroma With a New Bioresorbable Copolyester Nerve Capping Device: A Multicenter Prospective Cohort Study. Ann Plast Surg. 2023 Jul 1;91(1):109-116. doi: 10.1097/SAP.0000000000003596.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroma, run by Polyganics BV at 16 sites in 7 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 7 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: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Sweden, France, Germany, Italy and 2 more countries. 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?
Visual Analog Scale (VAS) for Pain (time frame: 2 years). 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 NCT02993276, 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 10 Sep 2020.