NCT02943070

Rezum I Pilot Study for Benign Prostatic Hyperplasia

NxThera Benign Prostatic Hyperplasia Rezum System Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of the Rezum System for the treatment of BPH

Detailed description

Prospective, non-randomized clinical trial of subjects with benign prostatic hyperplasia. The objective of the study are to 1) determine the safety and efficacy of the BPH Rezum System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH), and 2) further document the safety and post-operative effects of the Rezum System in the treatment of obstructive BPH.

Conditions

• Prostatic Hyperplasia
• Benign Prostatic Hyperplasia
• Adenoma, Prostatic
• Prostatic Adenoma
• Prostatic Hyperplasia, Benign
• Prostatic Hypertrophy
• Prostatic Hypertrophy, Benign
• Rezum

Interventions

Type	Name	Description
DEVICE	Rezum System	The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-02-01
• Completion: 2018-12-01
• First posted: 2016-10-24
• Last updated: 2021-03-16
• Results posted: 2021-02-24

Locations

3 sites across 3 countries: Czechia, Dominican Republic, Sweden