Halevy-Politch, Jacob
Zaaroor, Menashe
Sinai, Alon
Constantinescu, Marius
Article History
Received: 27 November 2019
Accepted: 24 June 2020
First Online: 5 August 2020
Ethics approval and consent to participate
: Before initiating the clinical trials, there were obtained approvals from the Helsinki committee of Rambam Health Care Center (HCC) [#0307-09-RMB, dated 13 June 2010], followed by the approval of the Israeli Ministry of Health (IMH) [#HT-A5534, dated 20 June 2011]. The NUD received the regulatory approval, after it was tested successfully in an “Independent Laboratory” for safety, electro-magnetic compatibility (EMC), sterilization, biocompatibility, and the intensity safety of the US pressure. Every neurosurgery that belonged to this research was performed only after explaining to the patient the additional measurements during the surgery to be performed and obtaining his written and signed agreement in the “patient’s consent.”
: Not applicable.
: There are no competing interests.