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Procedure

Rezum for Enlarged Prostate

N/A
Waitlist Available
Led By Bilal Chughtai, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to use the Rezum system, a steam-based treatment for an enlarged prostate, without needing a catheter afterward. It focuses on men with good bladder function to see if they can avoid the usual post-treatment catheter. Rezum is a minimally invasive water vapor therapy for benign prostatic hyperplasia (BPH) that uses thermal energy to treat prostate tissue.

Eligible Conditions
  • Enlarged Prostate

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
Secondary study objectives
Changes in urinary symptoms as measured by changes in IPSS.
Changes in urinary symptoms as measured by changes in Qmax at 36 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Catheterless groupExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,140 Total Patients Enrolled
Weill Medical College of Cornell UniversityLead Sponsor
1,088 Previous Clinical Trials
1,154,977 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
744 Previous Clinical Trials
857,783 Total Patients Enrolled

Media Library

Rezum (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04997369 — N/A
Enlarged Prostate Research Study Groups: Catheterless group
Enlarged Prostate Clinical Trial 2023: Rezum Highlights & Side Effects. Trial Name: NCT04997369 — N/A
Rezum (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997369 — N/A
~5 spots leftby Dec 2025
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