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

NCT03605745 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2021-08-10

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Henry Woo, MD · Sydney Adventist Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2020-06-25
Completion
2020-08-11
FDA Device
Yes

Countries

  • United States
  • Australia

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 NCT03605745 on ClinicalTrials.gov