A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Description

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

Conditions

Lumbar Spinal Stenosis

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Study Overview

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Study Details

Study overview

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

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Condition
Lumbar Spinal Stenosis
Intervention / Treatment

-

Contacts and Locations

Carlsbad

Coastal Research Institute, LLC, Carlsbad, California, United States, 92009

Larkspur

MarinHealth Spine Institute, Larkspur, California, United States, 94939

Rancho Mirage

Vitamed Research, Rancho Mirage, California, United States, 92270

Santa Rosa

Pacific Research Institute, Santa Rosa, California, United States, 95403

Walnut Creek

IPM Medical Group Inc., Walnut Creek, California, United States, 94598

Fort Lauderdale

Holy Cross Hospital, Fort Lauderdale, Florida, United States, 33308

Gainesville

The Orthopaedic Institute, Gainesville, Florida, United States, 32607

Sebastian

Florida Pain Management, Sebastian, Florida, United States, 32958

Atlanta

Alliance Spine and Pain Centers, Atlanta, Georgia, United States, 30326

Waycross

Centurion Spine and Pain, Waycross, Georgia, United States, 31501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 45 years of age or older when written informed consent is obtained
  • * Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
  • * Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal).
  • * Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
  • * Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
  • * Able to independently read and complete all questionnaires and assessments provided in English
  • * Axial back pain only.
  • * Fixed motor deficit in lower extremity(ies) due to LSS.
  • * Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor)
  • * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Scientific Corporation,

Natalie Bloom Lyons, STUDY_DIRECTOR, Boston Scientific Corporation

Study Record Dates

2032-06