SIU School of Medicine

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Rezum II

IRB Number

13-777

ClinicalTrials.gov Identifier

NCT01912339

Trial Status

Open for Enrollment
Phase 3

Why is this study being done?

The purpose of this study is to show whether a new device, the Rezūm System, is safe and works to lessen symptoms for an enlarged prostate gland, also called benign hyperplasia (BPH).

Who is eligible to participate?

Males 50 years of age or older who have levels of urinary complaints.

What is involved?

Those enrolled in the study will have a physical examination, physician assessments, and will be asked to complete questionnaires. Urine and blood samples will also be taken. Participants will undergo a one time, minimally invasive procedure (approximately 10 minutes), in the office clinic to help decrease the size of their prostate and improve their symptoms. One out of every three men will undergo the same minimally invasive procedure without receiving the actual treatment. This group of patients will be given a choice to undergo the actual treatment procedure after 3 months. Patients will then be seen at 2 weeks, 1 month, 3 months, 6 months, 12 months, and then annually for 4 more years after that, for a total of five years.

How long is the study?

The study lasts for a period of up to 5 years.

Who can I contact for additional information?

Please contact Kristal Adams, CCRP, at (217) 545-7812 or email kadams@siumed.edu

Who is the Principal Investigator of this study?

Kevin McVary, MD

Where is the trial located?

Springfield , Illinois