Clinical trial NCT04563793: Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Official title: Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-09-24
Enrollment: 129
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with moderate Lumbar Spinal Stenosis

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.

Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* Meets any contraindication in BSC Indirect Decompression Systems local IFU

Primary outcomes:
measure: Low Back Pain Responder Rate
timeFrame: Up to 3 years post-procedure
measure: Left Leg Pain Responder Rate
timeFrame: Up to 3 years post-procedure
measure: Right Leg Pain Responder Rate
timeFrame: Up to 3 years post-procedure
Secondary outcomes:
Other outcomes:
measure: Percent Low Back Pain Relief
timeFrame: Up to 3 years post-procedure
measure: Quality of Life (QoL)
timeFrame: Up to 3 years post-procedure
Locations:
city: Fountain Valley
country: United States
facility: Pain Medicine Associates
state: California
city: Larkspur
country: United States
facility: California Orthopedics & Spine
state: California
city: San Diego
country: United States
facility: Relieve Pain Center, Inc.
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Walnut Creek
country: United States
facility: IPM Medical Group Inc
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital Inc.
state: Florida
city: Jupiter
country: United States
facility: Louis J. Raso, MD, PA
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Port Charlotte
country: United States
facility: Southwest Florida Pain Center
state: Florida
city: Newnan
country: United States
facility: Georgia Pain and Spine Care, Inc.
state: Georgia
city: Waycross
country: United States
facility: Centurion Spine and Pain Centers
state: Georgia
city: Post Falls
country: United States
facility: North Idaho Day Surgery LLC
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lee's Summit
country: United States
facility: KC Pain Centers
state: Missouri
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management LLP
state: Nevada
city: Shrewsbury
country: United States
facility: Premier Pain Center
state: New Jersey
city: Somerset
country: United States
facility: University Clinical Research Center
state: New Jersey
city: Toledo
country: United States
facility: The Toledo Clinic
state: Ohio
city: Bryn Mawr
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Laredo
country: United States
facility: Advanced Spine Pain Solution
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: