Ongoing Clinical Studies
ReActiv8-A Clinical Trial
The ReActiv8-A clinical trial is an international, multi-centre, prospective single arm clinical trial with up to 96 subjects at sites in Australia and Europe. Outcome measures for the ReActiv8-A clinical trial are assessed at a three-month endpoint after activation of stimulation and compared to baseline prior to implant. Results from the first 47 patients enrolled in the ReActiv8-A Clinical Trial supported the CE-Marking of the system. Further details can be obtained at: https://clinicaltrials.gov/ct2/show/NCT01985230
ReActiv8-B Clinical Trial
The ReActiv8-B Clinical Trial is an international, multi-center, prospective randomized sham controlled blinded trial with one-way crossover, conducted under an Investigational Device Exemption (IDE). The statistical design of the Clinical Trial requires data from the pivotal cohort of 128 randomized subjects at the 120-day primary outcome assessment visit.
The primary efficacy endpoint of the ReActiv8-B Clinical Trial is a comparison of responder rates between the treatment and control arms. The Clinical Trial will be considered a success if there is a statistically significant difference in responder rates between the treatment and control arms. The Clinical Trial, if successful, will provide what is referred to as Level 1 Evidence of safety and efficacy of ReActiv8, which may be used to support applications for favourable reimbursement in the USA. Further details can be obtained at: https://clinicaltrials.gov/show/NCT02577354