CompletedNot Applicable

Postmarket Registry for Evaluation of the Superion® Spacer

United States1,674 participantsStarted 2016-11-28

Plain-language 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).

Who can participate

Age range45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Vertiflex® Patient Satisfaction Survey

Timeframe: 3 Week Follow-Up Visit

Vertiflex® Patient Satisfaction Survey

Timeframe: 6 Month Follow-Up Visit

Vertiflex® Patient Satisfaction Survey

Timeframe: 12 Month Follow-Up Visit

Trial details

NCT IDNCT04087811

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-03-01

Results submitted2022-02-28

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials