Medical device company NxThera has completed enrollment in its Rezūm II IDE clinical trial for the treatment of benign prostatic hyperplasia (BPH).
The trial will assess the use of Rezum System to treat obstructive prostate tissue by convectively delivering sterile water vapor, or steam, directly into the prostate in a minimally invasive procedure. The company claims that it can be performed in few minutes.
The multi-center clinical study is involved 195 men in the US, aged about 50 or above. These people were randomized 2:1 to treatment with the Rezum System versus a control procedure.
Co-principal investigators Kevin McVary and Claus Roehrborn said the Rezum II clinical trial is designed to collect comprehensive information for review and evaluation by FDA and physicians.
"We look forward to completing the required follow-up assessments and evaluating patients’ outcomes in conjunction with the promising data previously reported from NxThera’s single-arm Rezum trials," Roehrborn added.
NxThera president and CEO Bob Paulson said, "It was very rewarding and exciting to see independent clinical study teams at 14 U.S. sites complete recruitment and enrollment of the Rezum II trial in just 44 weeks, which speaks to the number of men who are seeking alternatives to currently available BPH treatments and procedures."
BPH symptoms comprise increased urination frequency, sudden urges to urinate, and weak urine flow.
In the US, around 32 million men with around 70% over age 60 experience symptoms of BPH.