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Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia

NCT06596590 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-09-19

No results posted yet for this study

Summary

Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezum is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, the guidelines offer no recommendation with regards to Rezum therapy for those with large-volume glands.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

Rezum

The Rezum System is designed to treat patients with urinary symptoms associated with BPH. The Rezum System utilizes radiofrequency current to generate thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate in controlled 9-second doses. The vapor 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.

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Principal Investigators

  • Hongqian Guo, PhD · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • China

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 NCT06596590 on ClinicalTrials.gov