SENZA-PVD2 Rev A
Research type
Research Study
Full title
Prospective Feasibility Clinical Single-Center Trial of the Senza™ Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Intractable Pain from Vascular Disease
IRAS ID
227770
Contact name
Ganesan Baranidharan
Contact email
Sponsor organisation
Nevro Corp
Duration of Study in the UK
2 years, 4 months, 17 days
Research summary
For this study, HF10 therapy is being used as per its approved labelling. Subjects participating in this study will undertake entry criteria evaluation, baseline assessments and an on the table trial stimulation. Those subjects with a successful trial (defined as >30% pain relief as assessed by the investigator) will receive a permanent implant of an IPG (Implantable Pulse Generator) and leads, and undergo 12 months of stimulation and follow up.
Subjects who sign the informed consent will undergo eligibility evaluations based on the inclusion and exclusion criteria. Baseline assessments will measure for pain, disability, functioning, medication use, quality of life, oxygen pressure measurements in the affected limbs, toe pressures, distance walked without pain and sleep.
Following device implant, the subject will be randomly assigned to one of two programming sequences:
• In sequence A, the dorsal stimulation will first be applied followed by ventral stimulation
• In sequence B, the ventral stimulation will first be applied followed by dorsal stimulation.
At the end of each phase of stimulation, the subject will return to the clinic for assessments of pain relief and adverse events. Subjects will keep a twice-daily pain diary during this Early Evaluation period. After the sequence has been completed, if the subject did not achieve greater than 30% relief with any SCS, they will exit the study.
Subjects who do achieve greater than 30% relief will continue with the study. These subjects will return to the clinic at 1-month, 3-months (several visits), 6-months, and 12-months post-IPG implant. Programming during the permanent implant will be to optimize therapy.
At the 3-month visit, subjects will undergo a Later Evaluation of the site of stimulation, where they will again be randomised to one of two testing sequences. At each visit, the subject will return to the clinic for assessments, walking performance, to complete questionnaires, and to document adverse events, if any. Following the 12-month permanent implant phase, the subject will have completed participation in the study.REC name
North East - York Research Ethics Committee
REC reference
17/NE/0225
Date of REC Opinion
26 Jul 2017
REC opinion
Further Information Favourable Opinion