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NESS L300 Plus System · 1 trial · 3 indications
The occurence of anticipated and unanticipated events will be documented at each scheduled evaluation. In addition, subjects will be instructed to report adverse events 24 hours per day during the study period.
Patient feedback regarding the safety of using the device as reported during the study sessions and the completion of a satisfaction questionnaire will also be used to assess the system's safety.
| Name | Type | Description |
|---|---|---|
| NESS L300 Plus System | DEVICE | The patients will receive the device for daily use of six (6) weeks. |
Inclusion Criteria: * Upper motor neuron lesion * Thigh muscle weakness - hamstrings or quadriceps strength of less than 4/5 according to manual muscle testing * Foot drop - toe drag during walking * Lower limb spasticity - 0-4 according to the modified Ashworth scale * Responsible mental state, ab...
The NESS L300 Plus System is used for foot drop, a condition where a person cannot lift the front part of the foot. It is also intended for thigh muscle weakness in the hamstrings or quadriceps, and for upper motor neuron injury or disease. The system is designed to assist with these motor impairments.
The NESS L300 Plus System is developed by Bioventus Inc., a company traded on the stock exchange under the ticker symbol BVS. Bioventus is the developer of this medical device system, which is being studied for its safety and performance in clinical trials.
The NESS L300 Plus System is in Phase 3 clinical development. It is an investigational device, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, but the system remains under clinical investigation for its intended uses.
The NESS L300 Plus System has one completed clinical trial, identified as NCT01237860. This Phase 3 study evaluated the safety and performance of the system in 45 participants with foot drop, thigh muscle weakness, or upper motor neuron injury or disease. The trial was conducted in Israel.
The NESS L300 Plus System is a distinct version of the NESS L300 device, designed to address additional muscle groups beyond foot drop. While the NESS L300 focuses on foot drop, the Plus System also targets thigh muscle weakness in the hamstrings or quadriceps, expanding its therapeutic scope.