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

NCT05587465 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2022-10-24

No results posted yet for this study

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.

Conditions

  • Spinal Lumbar Stenosis
  • Claudication, Intermittent

Interventions

DEVICE

Lobster Device

The intervention is performed percutaneously using the dedicated instrument set.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Sciently di Omar Sabry

    collaborator UNKNOWN

  • Medical Consulting srl

    collaborator UNKNOWN

  • Diametros Medical srl

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2024-10-01
Completion
2025-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05587465 on ClinicalTrials.gov