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

NCT02335489 | Terminated Results

• 1 other identifier: 14-SMI-2013
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• 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) to 10 (maximum).

  Baseline, 3, 6 and12-Months

Study Arms (1)

Treated Subjects

All subjects recruited and treated with the Axium neurostimulator

Device: Implantation with the commercially available Axium neurostimulator

Interventions

Implantation with the commercially available Axium neurostimulator DEVICE

Treated Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Neuropathic Pain of the Foot and/or Lower Leg

You may qualify if:

• Subject is at least 18 years old
• Subject is able and willing to comply with the follow-up schedule and protocol
• Chronic, intractable pain in the foot and/or lower leg 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
• Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain
• Subject is able to provide written informed consent

You may not qualify if:

• 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 implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
• Subject is unable to operate the device
• Subjects with indwelling devices that may pose an increased risk of infection
• Subjects currently has an active infection
• Subject has participated in another clinical investigation within 30 days
• Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
• Subject has been diagnosed with cancer in the past 2 years.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

AZ Nikolaas

Sint-Niklaas, Belgium

Location

Results Point of Contact

• Title: Roni Diaz
• Organization: St. Jude Medical

rdiaz@sjm.com

+1 972 309 8601

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 9, 2015
• Study Start: March 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 4, 2019
• Results First Posted: August 2, 2017

Record last verified: 2019-01

Locations

BE (1)