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NCT04563793 Clinical Trial

Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

Lumbar Spinal Stenosis Clinical Trial

— PRESS2  

Official title:
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04563793
Other study ID # A4086
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2020
Est. completion date March 20, 2023

Study information
Verified date June 2023
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 129
Est. completion date March 20, 2023
Est. primary completion date March 20, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Superion™ IDS
All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.

Locations
Country Name City State
United States Center for Interventional Pain and Spine Bryn Mawr Pennsylvania
United States Rush University Medical Center Chicago Illinois
United States Holy Cross Hospital Inc. Fort Lauderdale Florida
United States Pain Medicine Associates Fountain Valley California
United States Comprehensive and Interventional Pain Management LLP Henderson Nevada
United States Louis J. Raso, MD, PA Jupiter Florida
United States University of Kansas Hospital Kansas City Kansas
United States Advanced Spine Pain Solution Laredo Texas
United States California Orthopedics & Spine Larkspur California
United States KC Pain Centers Lee's Summit Missouri
United States Florida Pain Institute Merritt Island Florida
United States Georgia Pain and Spine Care, Inc. Newnan Georgia
United States Southwest Florida Pain Center Port Charlotte Florida
United States North Idaho Day Surgery LLC Post Falls Idaho
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 Premier Pain Center Shrewsbury New Jersey
United States University Clinical Research Center Somerset New Jersey
United States The Toledo Clinic Toledo Ohio
United States Precision Spine Care Tyler Texas
United States IPM Medical Group Inc Walnut Creek California
United States Centurion Spine and Pain Centers Waycross Georgia

Sponsors (1)
Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Percent Pain Relief Percent Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR) Up to 3 years post-procedure
Other Quality of Life (QoL) Change in overall quality of life at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (EQ-5D-5L) Up to 3 years post-procedure
Primary Low Back Pain Responder rate Proportion of subjects with an improvement of 20 mm for low back pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) Up to 3 years post-procedure
Primary Leg Pain Responder rate Proportion of subjects with an improvement of 20 mm for leg pain at 6 months, 1 year, 2 years, and 3 years post-procedure compared with Baseline (VAS) Up to 3 years post-procedure
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