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Rezum I Pilot Study for Benign Prostatic Hyperplasia

NCT02943070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-03-16

Study results available
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Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Kevin M Hagelin · Program Manager, Clinical Affairs, Boston Scientific

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-02-28
Completion
2018-12-31

Countries

  • Czechia
  • Dominican Republic
  • Sweden

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 NCT02943070 on ClinicalTrials.gov