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Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)


Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezum II)




To evaluate the safety and efficacy of the Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Study Status: Recruiting


Condition Intervention Phase
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptom
Device: Rezum System
Procedure: Rigid Cystoscopy

Verified by NxThera Inc December, 2013

Sponsored by: NxThera Inc
Information provided by: NxThera Inc identifier: NCT01912339

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Claus Roehrborn, MD., Principal Investigator
Kevin McVary, MD., Principal Investigator

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