NCT05587465

Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis

Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis: A Single Arm, Prospective, Mutli-Center Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Diametros Medical srl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to demonstrate the safety and effectiveness of the Lobster interspinous spacer device for the treatment of Lumbar Spinal Stenosis in comparison to an SSED-based performance goal.

Detailed description

After being informed about the study and potential risks, patients with Lumbar Spinal Stenosis matching inclusion and exclusion criteria giving written informed consent will undergo Lobster device implantation and followed-up for 2 years for radiological and clinical assessment in a single-arm, prospective, multicentric clinical trial.

Conditions

• Spinal Lumbar Stenosis
• Claudication, Intermittent

Interventions

Type	Name	Description
DEVICE	Lobster Device	The intervention is performed percutaneously using the dedicated instrument set.

Timeline

• Start date: 2022-10-05
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-10-20
• Last updated: 2022-10-24

Locations

1 site across 1 country: Italy