FBSSHFSCSNCT02787252
Stimwave HF SCS Pilot Study
A study testing Implant procedure, Freedom Spinal Cord Stimulation System in people with FBSS, run by Curonix LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- FBSS
- What is being tested?
- Implant procedure, Freedom Spinal Cord Stimulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion Criteria:
- Subject is ≥ 18 years of age at time of informed consent;
- Subjects have been diagnosed with chronic, intractable pain of the trunk and/or lower limbs with a VAS > 5cm (on a 10-cm scale);
- Subject diagnosis with chronic pain refractory to conventional medical management for at least 6 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
- Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
- Subject is male or non-pregnant female;
- Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of the investigator, using face-to-face encounters and the psychological testing described in the measures;
- Patient is capable of giving informed consent;
- Patient lives within reasonable distance from the study site (circumference of 75 km).
- Exclusion Criteria:
- Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
- Malignancies;
- Subject has post-herpetic neuralgia (shingles);
- Subject has an active systemic infection or is immune-compromised.
- Based on the medical opinion of the Principal Investigator the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
- Insulin-dependent diabetic who is not controlled through diet and/or medication;
- Bleeding complications or coagulopathy issues;
- Pregnant/lactating or not using adequate birth control;
- A life expectancy of less than one year;
- Any active implanted device whether turned off or on;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Clinical Pilot Study of High Frequency Wireless Spinal Cord Stimulation (SCS) in the Treatment of Chronic Pain With The Freedom Spinal Cord Stimulatory
The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain.
Read the detailed description
This is a non-blinded, short-term study for a maximum duration of 12 weeks in which 6 patients will receive a Freedom SCS System. Subjects will have chronic, intractable pain of the trunk and/or lower limbs refractory to standard medical treatment; including unilateral or bilateral pain. Stimulators will be placed in the epidural space and over exiting nerve roots at vertebrae levels:
- Bilateral T9-T10 epidural; B. Bilateral L1-L4 epidural. All Patients will be treated below perception threshold with High Frequency settings (10.000 Hz, 30 μs).
- Conditions
- FBSS
- Being tested
- Implant procedure, Freedom Spinal Cord Stimulation System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant procedure, Freedom Spinal Cord Stimulation SystemDevice
A needle is carefully inserted near the spinal cord. The stimulator is then slide through the needle to lay close to the spinal cord. The end of the stimulator is then sutured underneath the skin of the back.
| Study group | Role | What they receive |
|---|---|---|
| HF DRG | Experimental | HF DRG Implants Receives: Device: Implant procedure, Freedom Spinal Cord Stimulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Outcome (VAS)
The primary outcome is defined as the percentage of subjects who respond (50% average or more pain relief for back and leg pain) to SCS therapy at the end of 12 weeks post-implant of the system as compared to baseline with no increase in medication. The primary outcome will be measured with the VAS (100 mm line).
Measured: 12 weeks post-implant
Primary Safety Outcome (Adverse Events)
Incidence and severity of device related adverse events during the study
Measured: 12 weeks post-implant
Secondary outcomes (2)
VAS
Percentage change from baseline in VAS for back and leg pain
Measured: 12 weeks post-implant
ODI
Change from baseline in functionality using the ODI score
Measured: 12 weeks post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FBSSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787252
- Sponsor's protocol ID
- 30-00178
- Acronym
- HFSCS
- Status last verified
- Jun 2017
- First submitted
- 20 May 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Clinical Pilot Study of High Frequency Wireless Spinal Cord Stimulation (SCS) in the Treatment of Chronic Pain With The Freedom Spinal Cord Stimulatory
- ClinicalTrials.gov ID
- NCT02787252
- Acronym / sponsor ID
- HFSCS / 30-00178
- Conditions
- FBSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to observe the efficacy of stimulation on over all pain relief as reported in an initial cohort of 6 patients treated with the Freedom High Frequency Spinal Cord Stimulator (SCS) System for low back and/or leg pain.
Detailed description
This is a non-blinded, short-term study for a maximum duration of 12 weeks in which 6 patients will receive a Freedom SCS System. Subjects will have chronic, intractable pain of the trunk and/or lower limbs refractory to standard medical treatment; including unilateral or bilateral pain. Stimulators will be placed in the epidural space and over exiting nerve roots at vertebrae levels:
- Bilateral T9-T10 epidural; B. Bilateral L1-L4 epidural. All Patients will be treated below perception threshold with High Frequency settings (10.000 Hz, 30 μs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF DRG | Experimental | Device: Implant procedure, Freedom Spinal Cord Stimulation SystemHF DRG Implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant procedure, Freedom Spinal Cord Stimulation SystemA needle is carefully inserted near the spinal cord. The stimulator is then slide through the needle to lay close to the spinal cord. The end of the stimulator is then sutured underneath the skin of the back. | Device | HF DRG |
Primary outcome
Primary Efficacy Outcome (VAS)
Time frame: 12 weeks post-implant
The primary outcome is defined as the percentage of subjects who respond (50% average or more pain relief for back and leg pain) to SCS therapy at the end of 12 weeks post-implant of the system as compared to baseline with no increase in medication. The primary outcome will be measured with the VAS (100 mm line).
Primary Safety Outcome (Adverse Events)
Time frame: 12 weeks post-implant
Incidence and severity of device related adverse events during the study
2 secondary outcomes
VAS
Time frame: 12 weeks post-implant
ODI
Time frame: 12 weeks post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant procedure, Freedom Spinal Cord Stimulation System in people with FBSS, run by Curonix LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Outcome (VAS) (time frame: 12 weeks post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.