Senza CLP study

• Research type

  Research Study

• Full title

  A Clinical Study to Evaluate HF10™ Therapy in Patients with Chronic Intractable Leg Pain

• IRAS ID

  238971

• Contact name

  GIRISH VAJRAMANI

• Contact email

  girish.vajramani@uhs.nhs.uk

• Sponsor organisation

  Nevro Corp

• ISRCTN Number

  34834/11180496

• Duration of Study in the UK

  2 years, 7 months, 1 days

• Research summary

  Research Summary
  Subjects who sign the informed consent will be evaluated for eligibility, based on the study inclusion and exclusion criteria. Baseline assessments will also include measures for pain, disability, health status, medication use, and sleep. HF10 therapy is being used as per its approved labelling. Implantation and use of the HF10 will follow the Nevro Physician's Manual, supporting Manuals and centres’ routine practice. All attempts will be made to optimize therapy based on the Investigators evaluation.

  Subjects will undergo a Trial Phase lasting up to 28 days to determine the subject’s response to the SCS therapy (centres’ routine practice). Following the Trial Phase with external device stimulation, subjects will be assessed for their pain, and those who have a "successful Trial Phase" (defined as a 50% or greater pain reduction from Baseline in their pain) will proceed to permanent implantation of the SCS system.
  Those subjects with a successful Trial Phase will receive a permanent implant of an implantable pulse generator (IPG) and leads, and undergo 12 months of stimulation delivery with follow up and assessments at 1, 3, 6, 9 and 12 months after permanent device activation. The time between implant and activation will be up to 4 weeks providing time for surgical wounds to heal and for the implant medication to washout.
  At all time- points following activation, assessments and monitoring of pain and adverse events will be made.
  Subjects will be assessed for pain, disability, sleep disturbance, quality of life, mental and physical function, patient and clinician global impression of change, subject satisfaction, , work status, medication use and adverse events

  Summary of Results
  This prospective, observational, single-arm, multi-centre study was comprised of 121 subjects in the IIT-Baseline population, 90 in the Per Protocol and 96 in the Intention-to-Treat population. 96 subjects with moderate to severe leg pain either idiopathic in origin or from failed back surgery syndrome refractory to conservative therapy for a minimum of 3 months received a permanent implant.
  Effectiveness
  The primary endpoint was met, with a significant proportion of subjects (66.7%) experiencing at least 50% leg pain reduction compared to baseline as assessed by VAS.
  In evaluating each of the hierarchical secondary endpoints it was demonstrated that in addition to leg and back pain relief, significant improvements in function, quality of life, sleep and reduction in daily opioid use was achieved with 10kHz SCS in this population.
  The results reported here are consistent with those observed in Senza-RCT for low back and leg pain, currently approved indications for the Senza device, and no new safety issues have been identified.
  Safety
  Overall, 96 subjects were implanted and had accumulated approximately 90 implant years at the cut-off of this report. With this amount of exposure, the similarity in the observed safety profiles is comparable to the safety observed in the Senza-RCT.
  There were 186 AEs reported in 121 total subjects. Ten of those were study related SAEs. None of those SAEs were classified as stimulation related. Also, none of the SAEs were categorized as both unanticipated and device NEVRO CORP. 30-OCT-2021 CONFIDENTIAL CA2017EU CLP End of Study Report Revision A Page 7 related. The safety data is consistent with those previously identified in the Senza-RCT study, confirming the equivalency of the safety profiles in both patient populations.
  Benefit-Risk Assessment
  As such, the results of this study confirm the system is safe in this population (Chronic Intractable Leg Pain), as defined by 21 CFR 860.7(d) (1). The subjects in the study have demonstrated favourable primary and secondary endpoint results. The results of this study provide a reasonable assurance that the Senza System is effective in this population, as defined by 21 CFR 860.7(e) (1). This study demonstrates the probable benefits to health from use of the Senza System for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.
  Impact of Study Results on Patients with Chronic Intractable Leg Pain Many patients with chronic intractable leg pain do not achieve satisfactory pain relief with conservative or conventional medical management, and therefore there is a need for additional treatment options. This study provides important level evidence on the clinical efficacy, safety, and cost effectiveness of 10kHz SCS in this patient group, in order to support clinical decision making.
  With the positive results of this study, the Senza System with 10kHz will provide clinically meaningful outcomes to the target population. In doing so, the Senza System will have important health, quality of life, and economic benefits for patients with chronic intractable leg pain.

• REC name

  West of Scotland REC 4

• REC reference

  18/WS/0021

• Date of REC Opinion

  26 Mar 2018

• REC opinion

  Further Information Favourable Opinion