A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
COVERAGE
COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
1 other identifier
interventional
17
1 country
4
Brief Summary
The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-pain
Started Feb 2015
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
July 19, 2018
CompletedNovember 20, 2020
November 1, 2020
1.7 years
January 28, 2015
October 13, 2017
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Paresthesia Coverage ≥50%
Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.
7, 14 days post activation
Study Arms (2)
Conventional Programming, then Advanced Programming
ACTIVE COMPARATORPrecision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received conventional single source programming followed by Precision Spectra SCS System advanced programming.
Advanced Programming, then Conventional Programming
ACTIVE COMPARATORPrecision Spectra SCS System with CoverEdge Surgical Lead or more than 2 percutaneous leads. Subjects first received Precision Spectra SCS System advanced programming followed by conventional single source programming.
Interventions
Precision Spectra SCS System using conventional single source programming.
Precision Spectra SCS System using advanced programming
Eligibility Criteria
You may qualify if:
- Primary complaint of persistent or recurrent low back pain, with or without leg pain
- Signed a valid, IRB/EC-approved informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Physicians Research Group, LLC
Phoenix, Arizona, 85016, United States
Albany Medical Center
Albany, New York, 12208, United States
PCPMG Clinical Research Unit, LLC
Greenville, South Carolina, 29601, United States
Spine Team Texas
Rockwall, Texas, 75032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Sciences and Scientific Communication
- Organization
- Boston Scientific Neuromodulation
Study Officials
- STUDY DIRECTOR
Kristen Lechleiter, M.S.
Boston Scientific Neuromodulation Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2015
First Posted
March 10, 2015
Study Start
February 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 20, 2020
Results First Posted
July 19, 2018
Record last verified: 2020-11