SENZA - UEP
Research type
Research Study
Full title
A Multi-center, Prospective, Clinical Trial of the SenzaTM Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Pain of the Upper Extremities
IRAS ID
159495
Contact name
Wim Laloo
Contact email
Sponsor organisation
Nevro Corp.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
For this study, the Senza system is being used according to its approved guidelines and provided to the subjects as it would be at this site under normal practice. The implantation technique and use of the Senza System will follow the Nevro Physician’s and Patient’s Manuals. Subjects taking part in this study will be assessed for eligibility, have baseline assessments, undergo the trial stimulation phase and the have the post-trial assessment. Subjects who have a successful trial phase will receive a permanent implant and then have 12 months of stimulation and follow up visits at the clinic.\n\nSubjects who sign the informed consent will be evaluated for eligibility based on the study inclusion and exclusion criteria. Baseline assessments will measure for pain, disability, functioning, medication use, quality of life and sleep. Subjects will then undergo the trial phase to assess their response to the therapy. The subject’s pain scores will be compared to those recorded at baseline and those who have a “Successful Trial Phase“ ( ≥ 40% pain reduction from baseline in their primary pain area) will receive permanent implantation of the SCS system. \nFollowing device implant, the device is activated and stimulation delivered for 12 months. There will be 2 weeks between implant and activation, providing sufficient time for surgical wounds to heal and for the implant medication to be eliminated from the body.\n\nAt every follow up visit following device activation, tests and monitoring of pain and adverse events will be made. At 3, 6,and 12 months, subjects will be tested for disability, functioning, medication use, quality of life, and sleep. Paraesthesia assessment, neurological assessment, the patient’s impression of change, the doctor’s impression of change and the subject satisfaction with the therapy, will be completed at the 3 and 12 month visits. At every visit, all attempts to achieve the best possible pain relief therapy will be made, based on the doctor’s advice. All device programming will be performed by Nevro field clinical engineers.\n
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0187
Date of REC Opinion
24 Jun 2016
REC opinion
Further Information Favourable Opinion