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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001304426
Ethics application status
Approved
Date submitted
8/09/2016
Date registered
16/09/2016
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Date results information initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study evaluating the Nalu Stimulator for the treatment of chronic pain via Spinal Cord Stimulation
Scientific title
A 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)
Secondary ID [1] 290119 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain of the low back and/or legs 300222 0
Condition category
Condition code
Anaesthesiology 300099 300099 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A commercially approved (TGA approved) spinal cord stimulator lead will be percutaneously placed in the epidural space (near the spinal cord) by a qualified physician (pain anaesthetist or neurosurgeon) as per standard implantation techniques. The choice of the commercially approved device will be up to the patient and their doctor. The procedure typically takes less than 1 hour. The leads will then be connected to the Nalu external trial stimulator (ETS) and programmed. Programming may include a proprietary waveform intended to improve pain relief. Patients will be sent home with the NALU ETS for a maximum of 15 days. During this period the patients will return to the doctor’s office for the Nalu ETS to checked and patient assessments to be completed 3-12days after the implant. and again 3-12days later (maximum of 15 days) for the Nalu ETS trial completion after which the patient is returned to standard of care treatment . The duration of each trial period will be at the discretion of the patient and their doctor. The programming parameters used for each patient will be at the discretion of the patient and their doctor. There is no control group: all patients will receive the Nalu ETS devices. The ETS device (worn on their belt or clothing) allows the patient to turn up and down stimulation, turn on and off stimulation and to choose among pre-specified programs. Patients are expected to adhere to the study protocol and to use the devices as instructed by their doctor.
Intervention code [1] 295869 0
Treatment: Devices
Comparator / control treatment
There is no Comparator/Control group and any comparison will be made between the different settings of the Nalu External spinal cord stimulator for all patients .
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299577 0
Pain relief will be assessed by the visual analogue scale and numeric rating scale.
Timepoint [1] 299577 0
All assessments are made prior to and at the end of each trial period.
Secondary outcome [1] 327586 0
Pain relief will be evaluated on the basis of validated questionnaires (Brief Pain Inventory, and the Likert Scales).
Timepoint [1] 327586 0
All assessments are made prior to and at the end of each trial period.

Eligibility
Key inclusion criteria
1. Have a minimum or 1 surgical intervention of the lumbar spine
2..Have been diagnosed with chronic, intractable pain of the low back and/or legs.
3. Have been approved by their doctor to undergo a commercial trial of SCS.
4. Be an appropriate candidate for the surgical procedures required in this study.
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints.
2. Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
3. Have an active systemic or local infection
4. Be pregnant or nursing
5. Be concomitantly participating in another clinical study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA,VIC
Recruitment postcode(s) [1] 16768 0
6011 - Cottesloe
Recruitment postcode(s) [2] 16769 0
5007 - Welland
Recruitment postcode(s) [3] 16770 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 294495 0
Commercial sector/Industry
Name [1] 294495 0
Nalu Medical
Address [1] 294495 0
1525 Faraday Ave
STE 180
Carlsbad, CA 92008
Country [1] 294495 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nalu Medical
Address
1525 Faraday Ave
STE 180
Carlsbad, CA 92008
Country
United States of America
Secondary sponsor category [1] 293358 0
None
Name [1] 293358 0
Address [1] 293358 0
Country [1] 293358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295929 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 295929 0
Ethics committee country [1] 295929 0
Australia
Date submitted for ethics approval [1] 295929 0
01/09/2016
Approval date [1] 295929 0
16/09/2016
Ethics approval number [1] 295929 0

Summary
Brief summary
Nalu Medical (the sponsor) is developing an implantable medical device that is designed as an adjunctive therapy to medical management of patients with chronic pain in the trunk and/or limbs. To support the design and development of this implantable device, Nalu Medical has developed an External Trial Stimulator (ETS) for use during a trial of Spinal Cord Stimulation (SCS) prior to implanting the permanent device. All commercial devices are trialed in a similar manner, through the use of a proprietary ETS, prior to permanent implant. This study is intended to evaluate the Nalu ETS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68930 0
Dr John Salmon
Address 68930 0
Perth Pain Management
2/89 Forest Street
Perth COTTESLOE 6011
Western Australia
Country 68930 0
Australia
Phone 68930 0
+61 8 9284 6005
Fax 68930 0
Email 68930 0
JohnSalmon@bigpond.com
Contact person for public queries
Name 68931 0
Dr James Makous
Address 68931 0
Nalu Medical
1525 Faraday Ave
STE 180
Carlsbad, CA 92008
Country 68931 0
United States of America
Phone 68931 0
+1 760-448-2366
Fax 68931 0
Email 68931 0
jim@nalumed.com
Contact person for scientific queries
Name 68932 0
Dr James Makous
Address 68932 0
Nalu Medical
1525 Faraday Ave
STE 180
Carlsbad, CA 92008
Country 68932 0
United States of America
Phone 68932 0
+1 760-448-2366
Fax 68932 0
Email 68932 0
jim@nalumed.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual patient data will be made available to the public.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary