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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169401
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date June 13, 2014
First Posted Date June 23, 2014
Last Update Posted Date April 26, 2017
Study Start Date November 2012
Actual Primary Completion Date January 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2014)
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 ]
Original Primary Outcome Measures Same as current
Change History
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 Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain
Official Title a PRospEctive Post Market Trial of Drg stImulation With the Commercially Available Axium
Brief 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.
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 Pain Patients
Condition Chronic 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 Completed
Actual Enrollment
 (submitted: December 14, 2015)
135
Original Enrollment Not Provided
Actual Study Completion Date January 25, 2017
Actual Primary Completion Date January 25, 2017   (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 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
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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02169401
Other Study ID Numbers 08-SMI-2012 - PREDICT
Has Data Monitoring Committee Not Provided
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
Principal Investigator: S ElDabe, Prof James Cook University Hospital
PRS Account Abbott Medical Devices
Verification Date April 2017