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Evaluation of the Safety and Performance of the NESS L300 Plus System

NCT01237860 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-11-16

No results posted yet for this study

Summary

The study is designed to evaluate the safety and efficacy of using the L300 Plus as a neuroprosthesis device for walking in patients following an UMN injury or disease. The clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study.

Conditions

  • Foot Drop
  • Thigh Muscles Weakness (Hamstrings or Quadriceps)
  • Upper Motor Neuron Injury or Disease

Interventions

DEVICE

NESS L300 Plus System

The patients will receive the device for daily use of six (6) weeks.

Sponsors & Collaborators

  • Bioness Neuromodulation

    collaborator INDUSTRY

  • Bioness Inc

    lead INDUSTRY

Principal Investigators

  • Jean-Jacques Vatine, MD · Reuth Rehabilitation Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Israel

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 NCT01237860 on ClinicalTrials.gov