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A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg

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ClinicalTrials.gov Identifier: NCT02335489
Recruitment Status : Terminated (A significant local issue has to led to the suspension of recruitment, this study will be terminated in the coming months)
First Posted : January 9, 2015
Results First Posted : August 2, 2017
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date January 7, 2015
First Posted Date January 9, 2015
Results First Submitted Date April 24, 2017
Results First Posted Date August 2, 2017
Last Update Posted Date February 4, 2019
Study Start Date March 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 28, 2017)
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline [ Time Frame: Baseline, 3, 6 and12-Months ]
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).
Original Primary Outcome Measures
 (submitted: January 7, 2015)
Pain Relief - Assessed by Change in Pain Intensity from Pre-Treatment baseline [ Time Frame: Post implantation at; 1 week and 1, 3, 6 and12 months ]
Change History Complete list of historical versions of study NCT02335489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Official Title A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Brief Summary 14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Chronic Neuropathic Pain of the Foot and/or Lower Leg
Condition Chronic Neuropathic Pain
Intervention Device: Implantation with the commercially available Axium neurostimulator
Study Groups/Cohorts Treated Subjects
All subjects recruited and treated with the Axium neurostimulator
Intervention: Device: Implantation with the commercially available Axium neurostimulator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 25, 2016)
10
Original Estimated Enrollment
 (submitted: January 7, 2015)
30
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
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 foot and/or lower leg 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. Subject is able to provide written informed consent

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. Subject is unable to operate the device
  7. Subjects with indwelling devices that may pose an increased risk of infection
  8. Subjects currently has an active infection
  9. Subject has participated in another clinical investigation within 30 days
  10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
  11. Subject has been diagnosed with cancer in the past 2 years.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02335489
Other Study ID Numbers 14-SMI-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators Not Provided
PRS Account Abbott Medical Devices
Verification Date January 2019