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A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain (PREDICT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT02169401
First received: June 13, 2014
Last updated: April 24, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Chronic Pain Device: Implantation with the commercially available Axium Neurostimulator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: November 2012
Study Completion Date: January 25, 2017
Primary Completion Date: January 25, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treated subjects
All subjects recruited and treated with the Axium Neurostimulator
Device: Implantation with the commercially available Axium Neurostimulator

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Pain Patients
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 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 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

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 implantable cardioverter defibrillator, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02169401

Locations
United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: S ElDabe, Prof James Cook University Hospital
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT02169401     History of Changes
Other Study ID Numbers: 08-SMI-2012 - PREDICT
Study First Received: June 13, 2014
Last Updated: April 24, 2017

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 28, 2017