3.1
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 2 sources, which was discussed by the committee. The evidence included 1 single-arm clinical trial (3 papers) and 1 pilot study. It is presented in the summary of key evidence section in the overview. Other relevant literature is in the appendix of the overview. The committee also considered additional confidential documentation provided by a company.