NCT03605745

Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)

Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.

Detailed description

A prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.

Conditions

• BPH With Urinary Obstruction
• BPH
• BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
DEVICE	Prostatic Vapor Ablation	Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.

Timeline

• Start date: 2018-06-19
• Primary completion: 2020-06-25
• Completion: 2020-08-11
• First posted: 2018-07-30
• Last updated: 2021-08-10
• Results posted: 2021-08-10

Locations

10 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study