Peripheral NeuropathyNCT02349646

A Post Market Cohort With the Spinal Modulation Neurostimulator System in Peripheral Neuropathy

An observational study of Peripheral Neuropathy, run by Abbott Medical Devices at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Neuropathy
What is being tested?: Implantation with the commercially available Axium neurostimulator
Type of treatment: Medical device
How many people: 33 participants
Where: 1 siteGermany
Study dates: 25 Apr 2013to 24 Oct 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Neuropathy Patients

Who may be able to join

Subject is at least 18 years old
Subject is able and willing to comply with the follow-up schedule and protocol
Peripheral neuropathy for at least 6 months
Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
Subject is able to provide written informed consent

Who cannot join

Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
Escalating or changing pain condition within the past month as evidenced by investigator examination
Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
Subject is unable to operate the device

Show all 9Show fewer

Subjects currently has an active infection
Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator

Trial locations and contacts

1 site in 1 country.

Germany1 site

Heinrich Heine Universität Düsseldorf
Düsseldorf, 40225

Other trials in Germany

About this study

Official title: A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy

10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy

Conditions: Peripheral Neuropathy
Being tested: Implantation with the commercially available Axium neurostimulator
Medical subject headings: Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation with the commercially available Axium neurostimulatorDevice

Study groups in NCT02349646
Study group	Role	What they receive
Treated subjects		All subjects recruited and treated with the Axium neurostimulator Receives: Device: Implantation with the commercially available Axium neurostimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).
Measured: Baseline, 3, 6 and 12-Month Visits
Percentage of Subjects With at Least 50% Pain Reduction
Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).
Measured: 3, 6 and 12-Month Visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 201324 Oct 2016

First posted29 Jan 2015 (estimated)
Study start25 Apr 2013
Primary completion24 Oct 2016
Study completion24 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02349646
Sponsor's protocol ID: 10-SMI-2012
Status last verified: Oct 2019
First submitted: 7 Jan 2015
Last updated: 16 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Market Cohort With the Commercially Available Spinal Modulation Neurostimulator System for the Management of Peripheral Neuropathy
ClinicalTrials.gov ID: NCT02349646
Acronym / sponsor ID: 10-SMI-2012
Conditions: Peripheral Neuropathy
Study type: Observational
Recruitment status: Terminated
Enrolment: 33 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 25 Apr 2013 (actual)
Primary completion: 24 Oct 2016 (actual)
Study completion: 24 Oct 2016 (actual)
First posted: 29 Jan 2015 (estimated)
Results: Posted 26 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Treated subjects	–	Device: Implantation with the commercially available Axium neurostimulatorAll subjects recruited and treated with the Axium neurostimulator

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Peripheral Neuropathy Patients

Key inclusion criteria (7 listed)

Subject is at least 18 years old
Subject is able and willing to comply with the follow-up schedule and protocol
Peripheral neuropathy for at least 6 months
Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain

Key exclusion criteria (9 listed)

Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
Escalating or changing pain condition within the past month as evidenced by investigator examination
Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
Subject has had radiofrequency treatment of an intended target dorsal root ganglion within the past 3 months
Subject currently has an active implantable device including implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump

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
Implantation with the commercially available Axium neurostimulator	Device	Treated subjects

Primary outcome

Change in Pain Intensity for Overall Pain From Pre-treatment Baseline
Time frame: Baseline, 3, 6 and 12-Month Visits
The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).
Percentage of Subjects With at Least 50% Pain Reduction
Time frame: 3, 6 and 12-Month Visits
Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).

Results and safety

Results posted to the registry on 26 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Axium DRG Neurostimulator	33	16

Primary outcome: Change in Pain Intensity for Overall Pain From Pre-treatment Baseline

Time frame: Baseline, 3, 6 and 12-Month Visits. Mean (Standard Deviation). Unit: units on a scale

Measure	Subjected Treated With the Permanent Implantable Axium System n = 33
Baseline	7.4 (1.7)
3-Month Visit	4.0 (2.6)
6-Month Visit	3.4 (2.5)
12-Month Visit	3.8 (2.5)

Population analysed: Differences in participants over time is due to early withdrawals and missing data

Primary outcome: Percentage of Subjects With at Least 50% Pain Reduction

Time frame: 3, 6 and 12-Month Visits. Count of participants. Unit: Participants

Measure	Subjected Treated With the Permanent Implantable Axium System n = 23
3-Month Visit	13
6-Month Visit	14
12-Month Visit	8

Population analysed: Differences in participants over time is due to early withdrawals and missing data

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Subjects	8 of 33 (24.2%)	5 of 33 (15.2%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
Studying Nerve Function and Structure in Charcot-Marie-Tooth Disease, Anti-MAG Neuropathy and CIDP
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Neuropathy, run by Abbott Medical Devices 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 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: stopped early, as of the sponsor's last update on 16 Oct 2019. 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?

Yes. Results are posted in the registry (first posted 26 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Pain Intensity for Overall Pain From Pre-treatment Baseline (time frame: Baseline, 3, 6 and 12-Month Visits). The study lists 2 primary outcomes in all. 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 NCT02349646.

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 16 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.