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Thermal Therapy

Prolieve for Enlarged Prostate

Phase 4
Waitlist Available
Research Sponsored by Medifocus, 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 5 years
Awards & highlights

Study Summary

The primary objective of the post-marketing study is to collect safety and effectiveness data for 5 years on subjects treated with Prolieve®. The collection of 5-year safety information will be used to evaluate the occurrence of any long-term side effects from the treatment. The collection of long-term effectiveness data on subjects treated with Prolieve® will provide information on the long-term effects of treatment and time to re- treatment (any treatment initiated for BPH since Prolieve'" treatment, including a second treatment with Prolieve").

Eligible Conditions
  • Enlarged Prostate

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Re-Treatment
Secondary outcome measures
Change from Baseline in American Urological Association (AUA) Total Score at 5 years

Trial Design

1Treatment groups
Experimental Treatment
Group I: ProlieveExperimental Treatment1 Intervention
Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.

Find a Location

Who is running the clinical trial?

Medifocus, Inc.Lead Sponsor
1 Previous Clinical Trials
238 Total Patients Enrolled
Perry Weiner, MDStudy DirectorJefferson Urology

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Midtown Urologic Trials, PC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Will not try the standard drugs recommended due to side effects.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)
2006. "Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02021032.
All > Benign Prostatic Hyperplasia > Bph
~13 spots leftby Apr 2025
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