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

Chronic Pain Clinical Trial

— PREDICT  

Official title:

a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169401
• Other study ID #: 08-SMI-2012 - PREDICT
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: April 24, 2017
• Start date: November 2012
• Est. completion date: January 25, 2017

Study information

• Verified date: April 2017
• Source: St. Jude Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: January 25, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Implantation with the commercially available Axium Neurostimulator

Locations

Country	Name	City	State
United Kingdom	James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief - Assessed by Change in Pain Intensity from Pre-Treatment Baseline		Post implantation at; 1 week and 1, 3, 6, 12 and 24 months