Spinal Cord Stimulation Research Study | NCT00737581

Studies
Spinal Cord Stimulation Research Study

NCT00737581

Sponsor

MedtronicNeuro

Status

Completed

Last Update Posted

Feb 1, 2017Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Chronic Low Back and Leg Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Aug 15, 2008

First Submission Date that Met QC Criteria

Aug 18, 2008

First Posted Date

Aug 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be ambulatory
Be 18 years of age or older
Have chronic low back pain and/or leg pain due to neuropathic causes
Be implanted with the Restore or Restore Advanced system for greater than or equal to 3 months
Be implanted with percutaneous thoracic leads
Have stable pain control
Adjust stimulation parameters manually on a regular basis
Be willing and able to complete protocol requirements
Be willing and able to provide written informed consent
Be male or nonpregnant female

Exclusion Criteria:

Plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study
Be morbidly obese
Had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients implanted with a spinal cord stimulator.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M Schultz, MD	Medical Advanced Pain Specialists	Principal Investigator
Cristy Schade, MD	Center for Pain Control	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Advanced Pain Specialists (MAPS)		Edina	Minnesota	55435	United States
Center for Pain Control

Condition Browse Module

MeSH Terms

ID	Term
D000071700	Cone-Rod Dystrophies

Ancestor Terms

ID	Term
D015785	Eye Diseases, Hereditary
D005128	Eye Diseases
D058499	Retinal Dystrophies
D012162	Retinal Degeneration

Browse Leaves

Not provided

Browse Branches

Not provided