← Back to Search

Device

Study Arm 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

PEAK Trial 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.Check my eligibility

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.See study design

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.

PEAK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary efficacy endpoint is the average IPSS improvement from baseline to 12 months.

Secondary outcome measures

Semen Sub-Study Safety Secondary Endpoint

PEAK Trial Design

1Treatment groups

Experimental Treatment

Group I: Study ArmExperimental Treatment1 Intervention

Study consists of a single arm.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Urotronic Inc.Lead Sponsor

8 Previous Clinical Trials

840 Total Patients Enrolled

Steven Kaplan, MD, FACSPrincipal InvestigatorProfessor of Urology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current investigation open for participant enrollment?

"As per the details provided on clinicaltrials.gov, this investigation is presently seeking volunteers. The trial was first made public on February 7th, 2024 and underwent its most recent update on March 8th, 2024."

Answered by AI

What is the current participation count in this clinical trial?

"Affirmative. Details on clinicaltrials.gov highlight the ongoing recruitment of subjects for this particular medical trial. The trial was initially posted on February 7, 2024, and last revised on March 8, 2024. A total of 92 participants are sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study

2024. "Safety and Effectiveness of the Optilume® BPH Catheter System in a Post-Market Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06312722.

All > Benign Prostatic Hyperplasia > Paid Studies Minneapolis