Postmarket Registry for Evaluation of the Superion® Spacer

Completed

Conditions studied: Lumbar Spinal Stenosis

In brief

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).

Key facts

Study ID

NCT04087811

Run by

Boston Scientific Corporation

People needed

1674

Starts

2016-11-28

Expected to finish

2021-03-01

Last updated by the study team

2023-07-06

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male and female patients ≥45 years of age
• 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)

You may not qualify if…

• not contraindicated as described in the labeled indications for use

Where it is running

• 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
• (ACT) Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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