Zenflow Spring System for Benign Prostatic Hyperplasia

(BREEZE Trial)

Recruiting at 7 trial locations

Overseen By Joel Barra

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Zenflow, Inc.

Must not be taking: Anticholinergics, Anticoagulants, Alpha-blockers, others

Disqualifiers: Prostate cancer, Urethral stricture, Recurrent UTIs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Procedure

279 Participants Needed

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).

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. Specifically, you must stop taking anticoagulants and antiplatelets at least 3 days before the procedure, coumadin 5 days before, and certain other medications like alpha-blockers and anticholinergics within 2 weeks of the baseline evaluation.

What data supports the effectiveness of the Zenflow Spring System treatment for benign prostatic hyperplasia?

The Rezum System, a similar minimally invasive treatment for benign prostatic hyperplasia, has shown promising results in improving patients' quality of life by using water vapor therapy. This suggests that other minimally invasive treatments like the Zenflow Spring System may also be effective. ^{1 2 3 4 5}

Research Team

Claus Roehrborn, MD

Principal Investigator

UT Southwestern, Dallas, TX

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients randomized to the treatment group will undergo Zenflow Spring placement, while the control group will undergo a Sham procedure.

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. Control arm subjects are followed for 3 months, while treatment arm subjects are followed for 60 months.

3-60 months

Multiple visits (in-person)

Crossover

Control Arm 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.

60 months post Zenflow Spring implantation

Treatment Details

Interventions

• Sham Procedure
• Zenflow Spring System

Trial Overview 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.

Participant Groups

Group I: Roll-in Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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 Arm Active Control 1 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 Arm Placebo Group 1 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.

Who Is Running the Clinical Trial?

Zenflow, Inc.

Lead Sponsor

Trials

5

Recruited

440+

References

1. England pubmed.ncbi.nlm.nih.gov

Recent advances in managing benign prostatic hyperplasia: The Rezūm System. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Pressure flow study data in a group of asymptomatic male control patients 45 years old or older. [2019]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A computer program for the support of the treatment-diagnosis process for patients with benign prostatic hyperplasia]. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Postoperative medical treatment of lower urinary tract symptoms after benign prostatic hyperplasia surgery. Are we underestimating the problem? [2023]

5. England pubmed.ncbi.nlm.nih.gov

Real-world four-year functional and surgical outcomes of Rezum therapy in younger versus elderly men. [2023]