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NCT05587465: LB2CT01

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

Status unknown NA Last updated 24 October 2022
What this trial tests

NA trial testing Lobster Device in Spinal Lumbar Stenosis in 210 participants. Status unknown.

Timeline
5 October 2022
Primary endpoint
1 October 2024
1 October 2025

Quick facts

Lead sponsorDiametros Medical srl
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment210
Start date5 October 2022
Primary completion1 October 2024
Estimated completion1 October 2025
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Diametros Medical srl

Who can join

18 and older, any sex, with Spinal Lumbar Stenosis or Claudication, Intermittent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05587465.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing