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Catheterless Water Vapor Therapy for the Treatment of BPH

NCT04997369 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-30

No results posted yet for this study

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

DEVICE

Rezum

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Principal Investigators

  • Bilal Chughtai, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-13
Primary Completion
2024-06-21
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997369 on ClinicalTrials.gov