Postmarket Registry for Evaluation of the Superion® Spacer

NCT04087811 | Completed Results FDA Device

• 1 other identifier: 16-VISS-01
• Study Type: observational
• Target: 1,674
• Locations: 1 country
• Sites: 66

Brief Summary

To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).

Conditions

Lumbar Spinal Stenosis

Keywords

LSS

Outcome Measures

Primary Outcomes (3)

• Vertiflex® Patient Satisfaction Survey

  Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.

  3 Week Follow-Up Visit

• Vertiflex® Patient Satisfaction Survey

  Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.

  6 Month Follow-Up Visit

• Vertiflex® Patient Satisfaction Survey

  Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated. Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.

  12 Month Follow-Up Visit

Study Arms (1)

Superion® Indirect Decompression System (IDS)

Superion® Indirect Decompression System (IDS) - Interspinous Spacer

Device: Superion® Indirect Decompression System (IDS)

Interventions

Superion® Indirect Decompression System (IDS) DEVICE

Superion® Indirect Decompression System (IDS) (Superion® implant)

Superion® Indirect Decompression System (IDS)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis

You may qualify if:

• male and female patients ≥45 years of age
• symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
• meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)

You may not qualify if:

• not contraindicated as described in the labeled indications for use

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (66)

(ACT) Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

HOPE Research Institute

Scottsdale, Arizona, 85018, United States

Location

NuVation Pain Group

Buena Park, California, 90621, United States

Location

Comprehensive Pain Physicians

Burbank, California, 91505, United States

Location

Coastal Pain and Spinal Diagnostics

Carlsbad, California, 92009, United States

Location

Pain Medicine Associates

Fountain Valley, California, 92708, United States

Location

Valley Pain Management

Fresno, California, 93720, United States

Location

Pain Consultants of San Diego

La Mesa, California, 91942, United States

Location

California Orthopedics & Spine

Larkspur, California, 94939, United States

Location

Remedy Pain Solutions, Inc.

Marina del Rey, California, 90292, United States

Location

Newport Beach Headache & Pain

Newport Beach, California, 92660, United States

Location

Pain Consultants of San Diego- Poway

Poway, California, 92064, United States

Location

Relieve Pain Center

San Diego, California, 92103, United States

Location

Paul Kim MD Pain Management

San Diego, California, 92108, United States

Location

San Diego Comprehensive Pain Management Center

San Diego, California, 92108, United States

Location

Source Healthcare

Santa Monica, California, 90403, United States

Location

Evolve Restorative Center

Santa Rosa, California, 95403, United States

Location

Innovative Pain Treatment Solutions

Temecula, California, 92590, United States

Location

Intergrated Pain Management Medical Group, Inc.

Walnut Creek, California, 94598, United States

Location

Front Range Pain Medicine

Fort Collins, Colorado, 80525, United States

Location

The Orthopaedic & Sports Medicine Center

Trumbull, Connecticut, 06611, United States

Location

International Spine Pain & Performance Center

Washington D.C., District of Columbia, 20006, United States

Location

Southeast Spine Associates

Fort Lauderdale, Florida, 33308, United States

Location

Holy Cross Interventional Spine and Pain Medicine

Fort Lauderdale, Florida, 33334, United States

Location

Jacksonville Spine Center

Jacksonville, Florida, 32256, United States

Location

Jupiter Interventional Pain Management

Jupiter, Florida, 33477, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32953, United States

Location

Lake Nona Medical Arts

Orlando, Florida, 32827, United States

Location

Southwest Florida Pain Center

Port Charlotte, Florida, 33948, United States

Location

Florida Pain Management Associates

Sebastian, Florida, 32958, United States

Location

Tampa Pain Relief Center, Inc.

Tampa, Florida, 33613, United States

Location

The Spine Center of Southeast Georgia

Brunswick, Georgia, 31525, United States

Location

Georgia Pain and Spine Care

Newnan, Georgia, 30265, United States

Location

AXIS Spine Center

Coeur d'Alene, Idaho, 83815, United States

Location

AMITA Health Bolingbrook Pain Management Center

Bolingbrook, Illinois, 60440, United States

Location

Rush University Medical Center Department of Anesthesiology

Chicago, Illinois, 60612, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Neuroscience Research Center, LLC

Overland Park, Kansas, 66210, United States

Location

Pain Management Center of Paducah, KY

Paducah, Kentucky, 42003, United States

Location

Pain and Wellness

Cambridge, Massachusetts, 01960, United States

Location

Columbia Interventional Pain Center

Columbia, Missouri, 65203, United States

Location

Pain Management Associates

Lee's Summit, Missouri, 64086, United States

Location

Comprehensive and Interventional Pain Management

Henderson, Nevada, 89052, United States

Location

Advanced Pain Specialists

Reno, Nevada, 89511, United States

Location

Center for Pain Control at Jasper Ambulatory Surgical Center

Brick, New Jersey, 08723, United States

Location

Spine Institute of North America, LLC

East Windsor, New Jersey, 08520, United States

Location

Premier Pain Center

Shrewsbury, New Jersey, 07702, United States

Location

University Clinical Research Center

Somerset, New Jersey, 08873, United States

Location

Pain Management at Garden State Medical Center

Whiting, New Jersey, 08759, United States

Location

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

Location

Cincinnati Comprehensive Pain Center

Cincinnati, Ohio, 45014, United States

Location

Dayton Outpatient Center

Dayton, Ohio, 45432, United States

Location

Summit Medical Center

Edmond, Oklahoma, 73013, United States

Location

Performance Spine & Sports Physicians, PC

East Norriton, Pennsylvania, 19403, United States

Location

Center for Interventional Pain & Spine

Exton, Pennsylvania, 19341, United States

Location

SC Pain and Spine

Murrells Inlet, South Carolina, 29576, United States

Location

North Lake Pain Consultants

Conroe, Texas, 77340, United States

Location

Performance Pain and Sports Medicine

Houston, Texas, 77027, United States

Location

Fondren Orthopedic Group, LLC

Kingwood, Texas, 77339, United States

Location

Advanced Spine and Pain Center

San Antonio, Texas, 78240, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Southwest Spine and Pain

St. George, Utah, 84790, United States

Location

The Spine and Nerve Center of Saint Francis Hospital

Charleston, West Virginia, 25301, United States

Location

Advanced Pain Management

Greenfield, Wisconsin, 53221, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Roshini Jain, Sr. Director Clinical Sciences
• Organization: Boston Scientific

roshini.jain@bsci.com

16619494350

Study Officials

• Natalie Bloom Lyons

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: September 12, 2019
• Study Start: November 28, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 6, 2023
• Results First Posted: April 4, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (66)