Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04503109 |
Other study ID # |
NAL-01-2020-US |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 16, 2020 |
Est. completion date |
September 13, 2022 |
Study information
Verified date |
February 2023 |
Source |
Nalu Medical, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address
patient needs. The study will confirm the efficacy, safety, comfort and compliance with the
Nalu Neurostimulation System in adult subjects with chronic pain in the legs and back.
Patients who have been diagnosed with failed back surgery syndrome (FBSS) and meet other
study eligibility criteria will be enrolled in the study to receive the Nalu Neurostimulation
System.
Description:
The study is a prospective, multi-center, open-label, single-arm clinical study with each
subject serving as their own control. The study will confirm device efficacy, safety, comfort
and compliance with the system.
Subjects who meet the protocol specified eligibility criteria and provide documented informed
consent will be considered for study participation. There are three phases in the study:
Screening/Baseline Phase, Trial Phase, Permanent Implant Phase. On confirmation of
eligibility during the screening/baseline phase, subjects will enter the Trial Phase where
they will undergo a trial with the Nalu Neurostimulation System. Trials will be done per
standard clinical practice and per system IFU. Subjects receiving at least 50% reduction in
their back pain, during the trial phase, will continue to the permanent implant phase.
Eligible subjects will receive the Nalu Neurostimulation System per standard surgical and
medical practices and will be programmed for stimulation with one or more therapies to
optimize pain reduction. All subjects receiving a permanent implant will be followed for
3-months post device activation. They will visit the clinic at 1 month and 3-months follow-up
and programming, as required. Adverse Event data will also be collected to support a safety
endpoint.
Multiple outcome domains will be captured throughout the study to confirm system performance
and subject response to the device. These include Visual Analogue Scale (VAS) for pain,
Numeric Rating Scales for pain, EQ-5D (QoL), the Oswestry Disability Index (ODI), PROMIS
Sleep Disturbance SF, Beck's Depression Index (BDI), pain and paresthesia maps, pain and
wearability diaries.
At study completion, subjects will return to standard clinical practice.