Nalu Medical NAL-02-2016-FS SCS Feasibillity trial
Research type
Research Study
Full title
A European multi-centre, open-label, prospective, feasibility study evaluating the Nalu Alpha External Trial Stimulator for the treatment of chronic pain via Spinal Cord Stimulation (SCS)
IRAS ID
237978
Contact name
Vajramani Girish
Contact email
Sponsor organisation
Nalu Medical
Clinicaltrials.gov Identifier
DRKS0013981, DRKS Database
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
The Nalu Medical study is a pre-market feasibility study with an investigational device that is not yet approved for commercial purposes. The "Nalu Alpha External Trial (ETS) Stimulator" is intended for trial stimulation (no longer than 30 days) to evaluate safety and efficacy of spinal cord stimulation (SCS) on patients already implanted with commercially available SCS leads and also undergoing trial stimulation with the commercial device per standard of care.
Patients will be tested with the Nalu ETS stimulator after they have undergone implantation of standard commercial SCS leads. The Nalu ETS stimulator will be placed externally on the waist of the patient and connected to the leads. They will be followed for up to 15 days while using the Nalu ETS. Patients will return to the clinic for pain assessment, among other outcome measures. The data collected during this feasibility study will be used in designing a long-term safety and efficacy study using the "Nalu implantable spinal cord stimulator system".
The study is a multi-centre study in the EU and Australia and will be conducted initially at 1-3 NHS sites in England. It involves the placement of the neuro-stimulator and evaluation of the pain reduction through a set of questionnaires. 2 additional x-rays are taken to evaluate potential lead migration.
The study duration is up to 30 days in total. 3-12 days after the commercial leads implantation, the patient visits the site for the Nalu ETS stimulator placement where after the patient visits the site again within the next 1-2 weeks for a follow up visit. A final phone call follows 1 week thereafter and exit the trial. The patient then continues with the commercial neuro stimulator.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0364
Date of REC Opinion
28 Mar 2018
REC opinion
Further Information Favourable Opinion