CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 45 target
Drug / intervention
NESS L300 Plus Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01237860
NCT01237860Phase 3Completed

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

Bioness Inc·interventional·Posted Nov 10, 2010·Updated Nov 16, 2011

In Brief

A Phase 3 clinical trial evaluating NESS L300 Plus System for Foot Drop and 2 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.6 years ago

Interventions

NESS L300 Plus Systemdevice

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