Postmarket Outcomes Study for Evaluation of the Superion™ Spacer

NCT04563793 | Completed Results FDA Device

• 1 other identifier: A4086
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Percent Low Back Pain Relief

  Up to 3 years post-procedure

• Quality of Life (QoL)

  Up to 3 years post-procedure

Study Arms (1)

Superion™ IDS

All patients to receive IDS for the treatment of their moderate Lumbar Spinal Stenosis Symptoms.

Device: Superion™ IDS

Interventions

Superion™ IDS DEVICE

All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.

Superion™ IDS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with moderate Lumbar Spinal Stenosis

You may qualify if:

• 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

You may not qualify if:

• Meets any contraindication in BSC Indirect Decompression Systems local IFU

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (23)

Pain Medicine Associates

Fountain Valley, California, 92708, United States

Location

California Orthopedics & Spine

Larkspur, California, 94939, United States

Location

Relieve Pain Center, Inc.

San Diego, California, 92103, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Pacific Research Institute

Santa Rosa, California, 95403, United States

Location

IPM Medical Group Inc

Walnut Creek, California, 94598, United States

Location

Holy Cross Hospital Inc.

Fort Lauderdale, Florida, 33308, United States

Location

Louis J. Raso, MD, PA

Jupiter, Florida, 33477, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32953, United States

Location

Southwest Florida Pain Center

Port Charlotte, Florida, 33948, United States

Location

Georgia Pain and Spine Care, Inc.

Newnan, Georgia, 30265, United States

Location

Centurion Spine and Pain Centers

Waycross, Georgia, 31501, United States

Location

North Idaho Day Surgery LLC

Post Falls, Idaho, 83854, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

KC Pain Centers

Lee's Summit, Missouri, 64086, United States

Location

Comprehensive and Interventional Pain Management LLP

Henderson, Nevada, 89052, United States

Location

Premier Pain Center

Shrewsbury, New Jersey, 07702, United States

Location

University Clinical Research Center

Somerset, New Jersey, 08873, United States

Location

The Toledo Clinic

Toledo, Ohio, 43623, United States

Location

Center for Interventional Pain and Spine

Bryn Mawr, Pennsylvania, 19010, United States

Location

Advanced Spine Pain Solution

Laredo, Texas, 78041, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Boston Scientific Corporation

BSNClinicalTrials@bsci.com

855-213-9890

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 24, 2020
• Study Start: October 8, 2020
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-09

Locations

US (23)