The study objective is to evaluate the safety and feasibility of the Vivifi's Treatment. The Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical/subclinical varicoceles in men. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.
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PRIMARY SAFETY ENDPOINT
Timeframe: will be assessed up to 12-month post-procedure follow-up.
PRIMARY EFFICACY ENDPOINT
Timeframe: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.