Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Device: Superion™ IDS
- Registration Number
- NCT04563793
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
- Detailed Description
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
- Scheduled to receive or previously received a commercially approved Boston Scientific Indirect Decompression Systems, per local Instructions for Use (IFU)
- Signed a valid, IRB approved informed consent form
Key
- Meets any contraindication in BSC Indirect Decompression Systems local IFU
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Superion™ IDS Superion™ IDS All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.
- Primary Outcome Measures
Name Time Method Low Back Pain Responder Rate Up to 3 years post-procedure Proportion of subjects with an improvement of 20 mm during the last 7 days for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Left Leg Pain Responder Rate Up to 3 years post-procedure Proportion of subjects with an improvement of 20 mm during the last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
Right Leg Pain Responder Rate Up to 3 years post-procedure Proportion of subjects with an improvement of 20 mm during last 7 days for left leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Pain Medicine Associates
🇺🇸Fountain Valley, California, United States
California Orthopedics & Spine
🇺🇸Larkspur, California, United States
Relieve Pain Center, Inc.
🇺🇸San Diego, California, United States
Source Healthcare
🇺🇸Santa Monica, California, United States
Pacific Research Institute
🇺🇸Santa Rosa, California, United States
IPM Medical Group Inc
🇺🇸Walnut Creek, California, United States
Holy Cross Hospital Inc.
🇺🇸Fort Lauderdale, Florida, United States
Louis J. Raso, MD, PA
🇺🇸Jupiter, Florida, United States
Florida Pain Institute
🇺🇸Merritt Island, Florida, United States
Southwest Florida Pain Center
🇺🇸Port Charlotte, Florida, United States
Scroll for more (13 remaining)Pain Medicine Associates🇺🇸Fountain Valley, California, United States