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Device

Optilume Catheter for Enlarged Prostate (PEAK Trial)

N/A
Recruiting
Led By Steven Kaplan, MD, FACS
Research Sponsored by Urotronic Inc.
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 to 12 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to confirm that the Optilume BPH Catheter System is still safe and effective to use."

Who is the study for?
This trial is for men experiencing symptoms of an enlarged prostate, also known as Benign Prostatic Hyperplasia (BPH). Specific eligibility criteria are not provided, but typically participants should be adults with a diagnosis of BPH who meet certain health standards.
What is being tested?
The Optilume® BPH Catheter System is being tested in this study. The system is designed to treat urinary problems caused by an enlarged prostate. This post-market study aims to confirm its safety and effectiveness after it has been approved for use.
What are the potential side effects?
While specific side effects are not listed, common side effects from procedures involving catheters may include discomfort or pain during insertion, urinary tract infections, bleeding, and potential damage to the urethra.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 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
Change in International Prostate Symptom Score (IPSS)
Rate of a composite of treatment-related serious adverse events (SAEs)
Secondary study objectives
Change in Sperm Concentration

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: Study ArmExperimental Treatment1 Intervention
Optilume BPH Catheter System

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Who is running the clinical trial?

Urotronic Inc.Lead Sponsor
9 Previous Clinical Trials
1,340 Total Patients Enrolled
Steven Kaplan, MD, FACSPrincipal InvestigatorProfessor of Urology
~61 spots leftby Feb 2031
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