Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05587465
Status:
RECRUITING
Last Update Posted:
2022-10-24
First Post:
2022-10-17
Brief Title:
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis
Sponsor:
Diametros Medical srl
Organization:
Diametros Medical srl
Study Overview
Official Title:
Evaluation of Safety and Effectiveness of Lobster Dynamic Interspinous Spacer in Lumbar Spinal Stenosis A Single Arm Prospective Mutli-Center Study
Status:
RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LB2CT01
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None