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Brief Title: Rezum I Pilot Study for Benign Prostatic Hyperplasia
Official Title: NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study
Study ID: NCT02943070
Brief Summary: Evaluate the safety and efficacy of the Rezum System for the treatment of BPH
Detailed Description: Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University Hospital, Brno, , Czechia
Clinica Canela, La Romana, , Dominican Republic
Urologcentrum, Stockholm, , Sweden
Name: Kevin M Hagelin
Affiliation: Program Manager, Clinical Affairs, Boston Scientific
Role: STUDY_DIRECTOR