Restore Claims Characterization Study

This study has been completed.

Sponsor:

Information provided by:

MedtronicNeuro

ClinicalTrials.gov Identifier:

NCT00200122

First received: September 12, 2005

Last updated: January 20, 2009

Last verified: October 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2005
Last Updated Date	January 20, 2009
Start Date ^ICMJE	January 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 12, 2005)	The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00200122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 12, 2005)	Secondary outcome measures include pain relief, quality of life, function, patient and physician acceptance.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Restore Claims Characterization Study
Official Title ^ICMJE	Restore Claims Characterization Study
Brief Summary	The purpose of this study is to characterize the pain coverage capability of the RESTORE spinal cord stimulation (SCS) and assess health outcomes.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Diagnostic
Condition ^ICMJE	Chronic Refractory Pain Associated With Failed Back Surgery Syndrome, Epidural Fibrosis, Peripheral Causalgia, Complex Regional Pain Syndrome
Intervention ^ICMJE	Device: Spinal Cord Stimulation
Study Arm (s)	Not Provided
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 ^ICMJE	Completed
Enrollment ^ICMJE	100
Completion Date	August 2007
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Has chronic refractory pain associated with one of the conditions currently approved for spinal cord stimulation as follows: Failed Back Syndrome, Degenerative Disk Disease (DDD), Herniated Disk pain refractory to conservative and surgical interventions, Peripheral Causalgia, Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD). Primary pain in the lower half of the body. Exclusion Criteria: Requires, or will in the future, diathermy treatments. Had implanted spinal cord stimulation system within the last six months.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00200122
Other Study ID Numbers ^ICMJE	1617
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	MedtronicNeuro
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MedtronicNeuro
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top