Postmarket Outcomes Study for Evaluation of the Superion™ Spacer (PRESS2)

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Device: Superion™ IDS

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.

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• United States
  • California
    • Fountain Valley, California, United States, 92708
      • Pain Medicine Associates
    • Larkspur, California, United States, 94939
      • California Orthopedics & Spine
    • San Diego, California, United States, 92103
      • Relieve Pain Center, Inc.
    • Santa Monica, California, United States, 90403
      • Source Healthcare
    • Santa Rosa, California, United States, 95403
      • Pacific Research Institute
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group Inc
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc.
    • Jupiter, Florida, United States, 33477
      • Louis J. Raso, MD, PA
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
    • Port Charlotte, Florida, United States, 33948
      • Southwest Florida Pain Center
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Georgia Pain and Spine Care, Inc.
    • Waycross, Georgia, United States, 31501
      • Centurion Spine and Pain Centers
  • Idaho
    • Post Falls, Idaho, United States, 83854
      • North Idaho Day Surgery LLC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Missouri
    • Lee's Summit, Missouri, United States, 64086
      • KC Pain Centers
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive and Interventional Pain Management Llp
  • New Jersey
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Center
    • Somerset, New Jersey, United States, 08873
      • University Clinical Research Center
  • Ohio
    • Toledo, Ohio, United States, 43623
      • The Toledo Clinic
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Center for Interventional Pain and Spine
  • Texas
    • Laredo, Texas, United States, 78041
      • Advanced Spine Pain Solution
    • Tyler, Texas, United States, 75701
      • Precision Spine Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with moderate Lumbar Spinal Stenosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Superion™ IDS; All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.	Device: Superion™ IDS; All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low Back Pain Responder Rate	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)	Up to 3 years post-procedure
Left Leg Pain Responder Rate	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)	Up to 3 years post-procedure
Right Leg Pain Responder Rate	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)	Up to 3 years post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Low Back Pain Relief	Percent Low Back Pain Relief at 6 months, 1 year, 2 years and 3 years post-procedure compared with Baseline (PPR). PPR is a questionnaire assessing how much of the subject's low back pain has been relieved by treatment. Pain relief is expressed as a percentage from 0 - 100%.	Up to 3 years post-procedure
Quality of Life (QoL)	Percent of change from Baseline index score to the Follow-up timepoints index score using EQ-5D-5L. EuroQol Five Dimensions Five Level questionnaire (EQ-5D-5L) is comprised of a descriptive system and a visual analog scale (VAS). The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one. VAS is used to record the subject's self-rated health on a 20cm vertical line with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. To calculate the Index Value, responses are converted into a single score using a specific algorithm. Score ranges from 0.000 (representing death) to 1.000 (representing perfect health). The algorithm is based on public preferences, reflecting how different health states are valued by the general public.	Up to 3 years post-procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: A4086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes