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To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

NCT04823221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2022-03-02

Study results available
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Summary

A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study

Conditions

  • Benign Prostatic Hyperplasia (BPH)

Interventions

DEVICE

Rezūm System

The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ming Liu, Dr · Boao Yiling Life Care Center

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-10
Primary Completion
2021-08-01
Completion
2021-08-01
FDA Device
Yes

Countries

  • China

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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 NCT04823221 on ClinicalTrials.gov