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OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH (APEX Trial)

N/A
Recruiting
Research Sponsored by Urotronic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to through study completion, an average of 2 years.
Awards & highlights
No Placebo-Only Group

Summary

APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Eligible Conditions
  • Enlarged Prostate

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to through study completion, an average of 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
Secondary study objectives
Change in IPSS over time
Change in PVR over time
Change in Qmax (mL per second) over time
+2 more

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
This is the data collection study arm. There is no other arm in the study.

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Who is running the clinical trial?

Urotronic Inc.Lead Sponsor
9 Previous Clinical Trials
932 Total Patients Enrolled
~333 spots leftby Mar 2027
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