A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain

NCT ID: NCT02335502

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-07-31

Brief Summary

04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.

Conditions

Chronic Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treated Subjects

All subjects recruited and treated with the Axium neurostimulator

Implantation with the commercially available Axium neurostimulator

Intervention Type: DEVICE

Interventions

Implantation with the commercially available Axium neurostimulator

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is at least 18 years old

2. Subject is able and willing to comply with the follow-up schedule and protocol

3. Chronic, intractable pain in the thoracic, lumbar and/or sacral distribution(s) for at least 6 months

4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain

5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain

6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device

7. Subject is able to provide written informed consent

8. Subject speaks Dutch or English

Exclusion Criteria

1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control

2. Escalating or changing pain condition within the past month as evidenced by investigator examination

3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days

4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months

5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump

6. Patient has pain only or primarily within a cervical dermatomal distribution

7. Subject is unable to operate the device

8. Subjects with indwelling devices that may pose an increased risk of infection

9. Subjects currently has an active infection

10. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device

11. Subject has participated in another clinical investigation within 30 days

12. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation

13. Subject has been diagnosed with cancer in the past 2 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Erasmus MC Pijnbehandelcentrum

Rotterdam, , Netherlands

Countries

Netherlands

Other Identifiers

04-SMI-2012

Identifier Type: -

Identifier Source: org_study_id