A clinical study to evaluate HF10 therapy using surgical leads
| ISRCTN | ISRCTN10619673 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10619673 |
| Secondary identifying numbers | CA2018-4 INT SURPASS |
- Submission date
- 21/10/2019
- Registration date
- 22/10/2019
- Last edited
- 22/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Spinal cord stimulation (SCS) involves implanting a device that delivers small electrical fields to the spinal cord to provide pain relief in patients with chronic (long-term), intractable (hard to control) back and leg pain. Significant leg pain relief has been reported with traditional SCS which uses a low frequency (<1200 Hz), but there is limited long-term data supporting the use of low-frequency SCS in predominant back pain patients. Recent studies testing SCS using a frequency of 10 kHz (HF10 Therapy™) have shown that this treatment is effective and safe in patients with both back and leg pain. The results from these studies demonstrated that these patients had significant pain relief up to 24 months. The decreased pain in both back and leg were consistent throughout the studies with improvements in functional capacity with no perception of paresthesia (a burning or prickling sensation). The aim of this study is to test the performance of HF10 therapy with the surgical lead worldwide in patients with back and/or leg pain, as per centers’ routine practice.
Who can participate?
Patients aged over 18 with chronic, intractable back and/or leg pain
What does the study involve?
Participants undergo Spinal Cord Stimulation (SCS) at 10 kHz (HF10 therapy) as per the center’s usual practice. SCS involves the surgical placement of a surgical lead (which looks like a thin wire) into a small area near the spinal cord. Electrical stimulation is delivered through this wire by a small, battery-operated, rechargeable SCS implanted generator. Each patient is followed for 12 months after device activation. The participants attend regular clinic visits to complete questionnaires and to provide feedback on their pain. Successfully treated participants get a permanent device implanted as per the center’s routine clinical practice.
What are the possible benefits and risks of participating?
Participants may benefit from the SCS system to relieve their pain. There are no direct risks of taking part in this study, although the general risks of having a spinal stimulation device in place apply.
Where is the study run from?
Up to 40 pain centers in the USA and Europe
When is the study starting and how long is it expected to run for?
October 2018 to December 2021
Who is funding the study?
Nevro Corp (USA)
Who is the main contact?
Brad Gliner
gliner@nevro.com
Contact information
Public
1800 Bridge Parkway
Redwood City
CA 94065
United States of America
| Phone | 0061502510005 |
|---|---|
| gliner@nevro.com |
Scientific
1800 Bridge Parkway
Redwood City
CA 94065
United States of America
| Phone | 0016502510005 |
|---|---|
| gliner@nevro.com |
Study information
| Study design | Multi-center prospective observational clinical study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A prospective observational multicenter study of HF10 therapy using surgical leads |
| Study acronym | SURPASS |
| Study hypothesis | The purpose of this study is to assess the clinical performance of HF10 therapy delivered to the spinal cord through SURPASS™ surgical leads in subjects with chronic, intractable, back and/or leg pain of neuropathic origin. |
| Ethics approval(s) | USA: Approved 29/11/2018, Western Institutional Review Board, 1019 39th Avenue SE Suite 120, Puyallup, WA 98374-2115, USA; Tel: +1 (360) 252-2500, +1 (800) 562-4789; Email: clientservices@wirb.com), IRB Tracking Number: 20183112 Belgium: Approved 14/05/2019, AZ Delta, Commissie voor Medische Ethiek (Rode Kruisstraat 20, 8800 Roeselare, Belgium; Tel: +32 (0)56 52 22 31; Email: sigrid.deneve@azdelta.be), ref. 19019 |
| Condition | Chronic, intractable, back and/or leg pain of neuropathic origin |
| Intervention | As part of their standard care, participants undergo a trial (temporary evaluation period) of Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy) as per the center’s usual practice and following this, those for whom the trial treatment was successful have a permanent device implanted as per center’s routine clinical practice. Following device activation, participants are followed for a period of 12 months. The participants attend regular clinic visits, at 3, 6 and 12 months, to complete questionnaires, and to provide feedback on their pain, quality of life, disability, health status, satisfaction and work status. At these visits, the physicians will take assessments from the participants such as pain evaluation, medication usage and side effects (if any). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Responder rate at 3 months (a responder is defined as a subject who experiences ≥30% pain reduction compared to baseline as assessed by NRS & improvement in health status per the patient global impression of change questionnaire) |
| Secondary outcome measures | 1. Pain is measured using the numerical rating scale (NRS) at baseline, end of trial, 3, 6 and 12 months 2. Disability is measured using the Oswestry Disability Index (ODI) at baseline, 3, 6 and 12 months 3. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6 and 12 months 4. Opioid intake is measured using a medication log at baseline, end of trial, 3, 6, 12 months 5. Health status is measured using the patient/physician global impression of change questionnaire at end of trial, 3, 6, 12 months 6. Participant satisfaction with the therapy is measured using the subject satisfaction questionnaire at 3,6 and 12 months |
| Overall study start date | 01/10/2018 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Up to 339 participants will be enrolled |
| Participant inclusion criteria | 1. Have chronic intractable back pain and/or leg pain of neuropathic origin, as determined by the physician 2. An appropriate candidate for spinal cord stimulation and/or surgical lead placement as determined by the physician 3. Already scheduled for either a commercial trial with Nevro or a permanent implant of the Senza system (with surgical lead only) 4. Be 18 years of age or older at the time of enrollment 5. Be able to read and understand the Patient Informed Consent Form 6. Be willing and capable of giving informed consent |
| Participant exclusion criteria | 1. Contraindicated for surgical lead placement and/or spinal cord stimulation; physician should reference labeling for precautions, warnings and indications |
| Recruitment start date | 06/05/2019 |
| Recruitment end date | 31/12/2021 |
Locations
Countries of recruitment
- Belgium
- United States of America
Study participating centres
8800
Belgium
NY 12208
United States of America
Neenah
Wisconsin
54956
United States of America
Sponsor information
Industry
1800 Bridge Parkway
Redwood City
CA 94065
United States of America
| Phone | 001650251005 |
|---|---|
| gliner@nevro.com | |
"ROR" |
https://ror.org/02xcxe208 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned presentation of results to international congresses from the start of 2021 2. Planned publication in a peer-reviewed journal from the start of 2022 3. Additional documents (such as study protocol, statistical analysis plan, other) will be available upon request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Brad Gliner (gliner@nevro.com). |
Editorial Notes
22/10/2019: Trial's existence confirmed by ethics committee.
