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Brief Title: Rezum FIM Optimization Study
Official Title: Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System
Study ID: NCT02940392
Brief Summary: Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).
Detailed Description: Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Clinica Canela, La Romana, , Dominican Republic