NCT04997369

Catheterless Water Vapor Therapy for the Treatment of BPH

Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Rezum	The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).

Timeline

• Start date: 2021-10-13
• Primary completion: 2024-06-21
• Completion: 2027-06-01
• First posted: 2021-08-09
• Last updated: 2024-12-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study