Postmarket Registry for Evaluation of the Superion® Spacer
NCT ID: NCT04087811
Last Updated: 2023-07-06
Study Results
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View full resultsBasic Information
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COMPLETED
1674 participants
OBSERVATIONAL
2016-11-28
2021-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Superion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) - Interspinous Spacer
Superion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) (Superion® implant)
Interventions
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Superion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) (Superion® implant)
Eligibility Criteria
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Inclusion Criteria
* symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
* meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)
Exclusion Criteria
45 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Natalie Bloom Lyons
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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(ACT) Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
HOPE Research Institute
Scottsdale, Arizona, United States
NuVation Pain Group
Buena Park, California, United States
Comprehensive Pain Physicians
Burbank, California, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
Pain Medicine Associates
Fountain Valley, California, United States
Valley Pain Management
Fresno, California, United States
Pain Consultants of San Diego
La Mesa, California, United States
California Orthopedics & Spine
Larkspur, California, United States
Remedy Pain Solutions, Inc.
Marina del Rey, California, United States
Newport Beach Headache & Pain
Newport Beach, California, United States
Pain Consultants of San Diego- Poway
Poway, California, United States
Relieve Pain Center
San Diego, California, United States
Paul Kim MD Pain Management
San Diego, California, United States
San Diego Comprehensive Pain Management Center
San Diego, California, United States
Source Healthcare
Santa Monica, California, United States
Evolve Restorative Center
Santa Rosa, California, United States
Innovative Pain Treatment Solutions
Temecula, California, United States
Intergrated Pain Management Medical Group, Inc.
Walnut Creek, California, United States
Front Range Pain Medicine
Fort Collins, Colorado, United States
The Orthopaedic & Sports Medicine Center
Trumbull, Connecticut, United States
International Spine Pain & Performance Center
Washington D.C., District of Columbia, United States
Southeast Spine Associates
Fort Lauderdale, Florida, United States
Holy Cross Interventional Spine and Pain Medicine
Fort Lauderdale, Florida, United States
Jacksonville Spine Center
Jacksonville, Florida, United States
Jupiter Interventional Pain Management
Jupiter, Florida, United States
Florida Pain Institute
Merritt Island, Florida, United States
Lake Nona Medical Arts
Orlando, Florida, United States
Southwest Florida Pain Center
Port Charlotte, Florida, United States
Florida Pain Management Associates
Sebastian, Florida, United States
Tampa Pain Relief Center, Inc.
Tampa, Florida, United States
The Spine Center of Southeast Georgia
Brunswick, Georgia, United States
Georgia Pain and Spine Care
Newnan, Georgia, United States
AXIS Spine Center
Coeur d'Alene, Idaho, United States
AMITA Health Bolingbrook Pain Management Center
Bolingbrook, Illinois, United States
Rush University Medical Center Department of Anesthesiology
Chicago, Illinois, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
Pain Management Center of Paducah, KY
Paducah, Kentucky, United States
Pain and Wellness
Cambridge, Massachusetts, United States
Columbia Interventional Pain Center
Columbia, Missouri, United States
Pain Management Associates
Lee's Summit, Missouri, United States
Comprehensive and Interventional Pain Management
Henderson, Nevada, United States
Advanced Pain Specialists
Reno, Nevada, United States
Center for Pain Control at Jasper Ambulatory Surgical Center
Brick, New Jersey, United States
Spine Institute of North America, LLC
East Windsor, New Jersey, United States
Premier Pain Center
Shrewsbury, New Jersey, United States
University Clinical Research Center
Somerset, New Jersey, United States
Pain Management at Garden State Medical Center
Whiting, New Jersey, United States
Upstate Orthopedics
East Syracuse, New York, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Cincinnati Comprehensive Pain Center
Cincinnati, Ohio, United States
Dayton Outpatient Center
Dayton, Ohio, United States
Summit Medical Center
Edmond, Oklahoma, United States
Performance Spine & Sports Physicians, PC
East Norriton, Pennsylvania, United States
Center for Interventional Pain & Spine
Exton, Pennsylvania, United States
SC Pain and Spine
Murrells Inlet, South Carolina, United States
North Lake Pain Consultants
Conroe, Texas, United States
Performance Pain and Sports Medicine
Houston, Texas, United States
Fondren Orthopedic Group, LLC
Kingwood, Texas, United States
Advanced Spine and Pain Center
San Antonio, Texas, United States
Precision Spine Care
Tyler, Texas, United States
Southwest Spine and Pain
St. George, Utah, United States
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia, United States
Advanced Pain Management
Greenfield, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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16-VISS-01
Identifier Type: -
Identifier Source: org_study_id
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