2 results
Approved WMOCompleted
Primary objective1. To test the safety of cold plasma treatment: SAE in * 10% of participants, no pain (VAT * 2) and no local skin reaction: redness, blister formation, pain or itching. Secondary objectives:The effect of cold plasma treatment on : 1…
Approved WMORecruiting
The purpose of this investigation is to confirm long-term clinical performance and safety of the InterStim Micro System. The primary objectives of the study will evaluate data at 3 months post-implant; however, subjects will be followed for 2 years…