Overview

This trial is active, not recruiting.

Condition chronic pain
Treatment implantation with the commercially available axium neurostimulator
Sponsor Spinal Modulation, Inc.
Start date November 2012
End date May 2017
Trial size 135 participants
Trial identifier NCT02169401, 08-SMI-2012 - PREDICT

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
All subjects recruited and treated with the AxiumNeurostimulator
implantation with the commercially available axium neurostimulator

Primary Outcomes

Measure
Pain Relief - Assessed by Change in Pain Intensity from Pre-Treatment Baseline
time frame: Post implantation at; 1 week and 1, 3, 6, 12 and 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 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. Average baseline pain rating of 60 mm on the VAS 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 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 DRG within the past 3 months 5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump 6. Subject is unable to operate the device 7. Subjects currently has an active infection 8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device 9. Subject has participated in another clinical trial 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

Additional Information

Official title a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium
Principal investigator S ElDabe, Prof
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Spinal Modulation, Inc..