A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Status: Active_not_recruiting
Location: See all (23) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 45 years of age or older when written informed consent is obtained

• Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).

• Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).

• Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.

• Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.

• Able to independently read and complete all questionnaires and assessments provided in English

Locations
United States
California
Coastal Research Institute, LLC
Carlsbad
MarinHealth Spine Institute
Larkspur
Vitamed Research
Rancho Mirage
IPM Medical Group Inc.
Walnut Creek
Florida
Holy Cross Hospital
Fort Lauderdale
The Orthopaedic Institute
Gainesville
Georgia
Alliance Spine and Pain Centers
Atlanta
Centurion Spine and Pain
Waycross
Idaho
North Idaho Day Surgery
Post Falls
Illinois
Rush University Medical Center
Chicago
Ascension Alexian Brothers
Elk Grove Village
Kansas
University of Kansas Hospital
Kansas City
Neuroscience Research Center, LLC
Overland Park
Massachusetts
Brigham and Women's Hospital
Boston
Michigan
Michigan Pain Specialists
Ypsilanti
New York
Weill Cornell Medical University
New York
Oregon
Pacific Sports and Spine, LLC
Eugene
Pennsylvania
Center for Interventional Pain and Spine
Lancaster
South Carolina
SC Pain and Spine Specialists
Murrells Inlet
Texas
Precision Spine Care
Tyler
Washington
Swedish Health Services
Seattle
Northwest Pain Care
Spokane
West Virginia
The Spine and Nerve Center of Saint Francis Hospital
Charleston
Time Frame
Start Date: 2020-01-30
Completion Date: 2041-02
Participants
Target number of participants: 166
Treatments
Experimental: Superion™ IDS device
Superion™ Indirect Decompression System (IDS)
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.