Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05177354




Registration number
NCT05177354
Ethics application status
Date submitted
30/11/2021
Date registered
4/01/2022
Date last updated
22/04/2024

Titles & IDs
Public title
Medtronic Closed-Loop Spinal Cord Stimulation System
Scientific title
Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System
Secondary ID [1] 0 0
MDT21017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 0 0
Leg Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* 18 years of age or older
* Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
* If being treated for low-back and/or leg pain,

* the baseline overall^ Visual Analog Scale is = 60 mm and
* baseline back and/or leg pain Visual Analog Scale is =60 mm. ^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale.
* If being treated for upper limb pain - baseline Visual Analog Scale is = 60 mm for upper limb pain
* On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial
* Willing and able to provide signed and dated informed consent
* Willing and able to comply with all study procedures and visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
* Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
* Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
* Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
* Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator
* Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
* Be involved in an injury claim or under current litigation

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedtronicNeuro
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Russo, MD
Address 0 0
Genesis Research Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05177354