5 results
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
The objective of this study is to assess the feasibility of SCS using the Wavewriter Alpha for control of treatment resistant endometriosis-related pain symptoms
To validate the results from two RCTs that SCS is indeed capable of treating otherwise refractory diabetic neuropathic pain, and to evaluate the effects of burst stimulation settings in this patient group.
To demonstrate that SCS is capable of treating otherwise refractory neuropathic pain after chemotherapy / radiotherapy.
To evaluate and quantify the various clinical effects of closed-loop SCS versus open-loop SCS on the underlying pathophysiological effects in CRPS.