US-based medical device company NxThera has announced the treatment of the first patients with its Rezum system in the Rezum II US investigational device exemption (IDE) clinical trial.
The Rezum system is an investigational device that is developed to rapidly treat prostate tissue by using sterile water vapor, or steam, in an office-based, minimally invasive procedure designed to treat the urethral obstruction caused by benign prostatic hyperplasia (BPH).
Dr Steven Gange of Western Urological Clinic used the Rezum system to enroll and treat the first patients in the Rezum II clinical trial, a randomized controlled study for male patients with 50 years of age or above who have urinary problems related to BPH.
Dr Gange noted millions of men who suffer from the effects of BPH are unable to obtain relief using pharmacologic therapies, and are unwilling to accept the potential complications or side effects associated with other BPH procedures.
"Many of these men are seeking treatment options that can be performed quickly, with minimal side effects and rapid recovery.
"The therapeutic objectives of the Rezum System are to treat the symptoms of BPH in an office-based procedure that can be performed in minutes, with minimal discomfort and rapid symptom relief by alleviating obstruction of the urethra while preserving normal sexual function. This trial has been designed to address this unmet medical need," Gange added.
NxThera anticipates enrollment of 195 patients at 15 sites in the US in the Rezum II clinical trial.