Zenflow Spring System for Benign Prostatic Hyperplasia
(BREEZE Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byClaus Roehrborn, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Zenflow, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing the Zenflow Spring System, a small device that helps men with urinary problems due to an enlarged prostate. It works by keeping the urinary pathway open, making it easier to urinate. The Zenflow Spring System is a novel device designed to alleviate lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH).

Eligibility Criteria

Men over 45 with moderate to severe urinary symptoms due to enlarged prostate, not responding well to medications. They should have a prostate size of 25-80 cc and be willing to follow study procedures. Excluded are those allergic to nickel, life expectancy under 5 years, bladder stones, certain medication use affecting bladder function, urethral strictures or anatomical anomalies unsuitable for the implant.

Inclusion Criteria

My prostate urethra length is between 25 and 45 mm.

I have tried and cannot tolerate medication for urinary symptoms, or I chose not to take them.

Your prostate size is between 25 and 80 cc, as measured by a transrectal ultrasound within 120 days of agreeing to join the study.

+5 more

Exclusion Criteria

I have taken medication for prostate enlargement within the last 3 months.

You are not expected to live for at least 5 years.

Your urine flow test shows that you have a low urine volume, a very slow or very fast urine flow rate, or a high leftover urine volume after using the restroom.

+20 more

Participant Groups

The trial is testing the Zenflow Spring System's ability to relieve lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). Participants will either receive this new treatment or a sham procedure (a fake treatment) for comparison.

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Roll-in CohortExperimental Treatment1 Intervention

Each Investigator will be allowed to treat up to 3 roll-in subjects with the Spring Implant prior to initiation of randomization. Roll-in patients will be followed for 60 months.

Group II: Crossover CohortExperimental Treatment1 Intervention

Control Arm (Sham) patients can receive treatment with the Zenflow Spring System after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met. The study visit follow-up schedule will restart and the subject will be followed for 60 months post Zenflow Spring implantation. Unless treated with the Spring System, the subject will be exited from the study once they have completed their 3-month follow-up visit.

Group III: Treatment ArmActive Control1 Intervention

Includes all patients who are randomized and start the treatment procedure. During the procedure the patient will be shielded from the treatment area and cystoscopy screen. The patient and site personnel administering follow-up assessments will be blinded to the study arm through the 3-month follow-up visit. Unblinding will occur at 3 months post-procedure after the assessments are completed. Follow up will continue for 60 months.

Group IV: Control ArmPlacebo Group1 Intervention

Includes all patients who receive a sham procedure. Patients will be shielded from the treatment area and cystoscopy screen. A Foley Catheter is placed into the patient's bladder and inflated. Additionally, devices will be used to produce mock deployment sounds of the Zenflow procedure. Once complete, the balloon will be deflated and the catheter will be removed, completing the procedure. Control arm subjects are followed for 3 months and exited from the study unless they elect and qualify for Crossover.