NCT04087811

Postmarket Registry for Evaluation of the Superion® Spacer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,674 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DEVICE	Superion® Indirect Decompression System (IDS)	Superion® Indirect Decompression System (IDS) (Superion® implant)

Timeline

• Start date: 2016-11-28
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2019-09-12
• Last updated: 2023-07-06
• Results posted: 2023-04-04

Locations

66 sites across 1 country: United States

Regulatory

• FDA-regulated device study