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Postmarket Registry for Evaluation of the Superion® Spacer (PRESS)

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ClinicalTrials.gov Identifier: NCT04087811
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
VertiFlex, Incorporated

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).

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Device: Superion® Indirect Decompression System (IDS)

Detailed Description:
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Postmarket Registry for Evaluation of the Superion® Spacer
Actual Study Start Date : November 28, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort Intervention/treatment
Superion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) - Interspinous Spacer
Device: Superion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) (Superion® implant)




Primary Outcome Measures :
  1. Vertiflex® Patient Satisfaction Survey [ Time Frame: 3 Week Follow-Up Visit ]
    A score of ≥3 in each questionnaire component will be deemed a clinically meaningful outcome

  2. Vertiflex® Patient Satisfaction Survey [ Time Frame: 6 Month Follow-Up Visit ]
    A score of ≥3 in each questionnaire component will be deemed a clinically meaningful outcome

  3. Vertiflex® Patient Satisfaction Survey [ Time Frame: 12 Month Follow-Up Visit ]
    A score of ≥3 in each questionnaire component will be deemed a clinically meaningful outcome

  4. Visual Analogue Scale (VAS), Back and Leg Pain [ Time Frame: Pre-Operative Assessment, 3 Week, 6 Month and 12 Month Follow-Up Visit ]
    A change of 20 mm (on a 100 mm scale) from baseline is considered a clinically meaningful outcome

  5. Achievement of Self-Defined Functional Objective [ Time Frame: Pre-Operative Assessment, 3 Week, 6 Month and 12 Month Follow-Up Visit ]
    A change of ≥3 is considered evidence of significant improvement in function



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • not contraindicated as described in the labeled indications for use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087811


Contacts
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Contact: Stephen Reitzler 442.325.5934 sreitzler@vertiflex.com
Contact: Leslie Zaccari 442.325.5992 lzaccari@vertiflex.com

Locations
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United States, California
Vertiflex, Inc. Clinical Research Recruiting
Carlsbad, California, United States, 92010
Contact: Vertiflex    866-355-4675    clinical@vertiflex.net   
Sponsors and Collaborators
VertiFlex, Incorporated
Investigators
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Study Director: Stephen Reitzler Sponsor, Vertiflex

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Responsible Party: VertiFlex, Incorporated
ClinicalTrials.gov Identifier: NCT04087811     History of Changes
Other Study ID Numbers: 16-VISS-01
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VertiFlex, Incorporated:
LSS
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases