Zenflow Spring System for Benign Prostatic Hyperplasia

(BREEZE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Zenflow Spring System, designed to relieve urinary problems from an enlarged prostate, known as benign prostatic hyperplasia (BPH). Participants will receive either the actual treatment or a sham procedure for comparison. Those in the sham group may later receive the real treatment if needed. This trial may suit individuals who have tried medication for BPH without success or have chosen not to take medication. As an unphased trial, it offers participants the chance to explore a novel treatment option for BPH that might not be available elsewhere.

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 prior data suggests that the Zenflow Spring System is safe for relieving LUTS associated with BPH?

Research shows that the Zenflow Spring System is generally well-tolerated. Studies have found significant symptom improvements in patients using this system. For example, symptoms like difficulty urinating, common in benign prostatic hyperplasia (BPH), improved by 46%.

These improvements are not just short-term; they lasted for at least three years, supporting the treatment's long-term safety and effectiveness. Few reports of serious side effects suggest that the treatment is safe for most people.

Overall, current research suggests the Zenflow Spring System is a promising option for relieving urinary symptoms caused by BPH, with safety supported by several years of patient data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Zenflow Spring System because it offers a new approach to treating Benign Prostatic Hyperplasia (BPH) that differs from traditional methods like medications, surgery, or other minimally invasive procedures. Unlike these standard treatments, which often involve cutting or removing tissue, the Zenflow Spring System utilizes a unique implant that gently opens the blocked urethra, potentially reducing symptoms without the need for extensive surgery. This method may lead to fewer side effects and a quicker recovery for patients. Additionally, the Spring System's design is intended to maintain its position permanently, providing long-lasting relief from BPH symptoms.

What evidence suggests that the Zenflow Spring System is effective for relieving LUTS associated with BPH?

Research has shown that the Zenflow Spring System, which participants in this trial may receive, effectively treats symptoms of benign prostatic hyperplasia (BPH), a condition affecting the prostate. In studies, patients experienced a 46% improvement in their symptom scores, which measure the severity of BPH symptoms, over three years. Their quality of life improved by at least 50%, and their urine flow increased by over 30%. These results suggest that the Zenflow Spring System provides lasting relief from BPH symptoms. The evidence indicates that this treatment is both long-lasting and beneficial for people with this condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Claus Roehrborn, MD

Principal Investigator

UT Southwestern, Dallas, TX

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-press-releases/160191-three-year-data-of-zenflow-s-spring-system-demonstrate-durability-of-clinical-benefits-for-patients-suffering-from-bph.html

Three-Year Data of Zenflow's Spring System Demonstrate ... Three-Year Data of Zenflow's Spring System Demonstrate Durability of Clinical Benefits For Patients Suffering from BPH · At 36 months, IPSS was 46% improved ...

2. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109800.53897.68.12

PD08-12 36-MONTH OUTCOMES FROM THE ZEST PILOT ... Subjects treated with the Zenflow Spring showed statistically significant and sustained reduction in IPSS from baseline at all assessment time ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03595735

Study Details | NCT03595735 | The Zenflow Spring System ... Each response has an assigned value between 0 and 5. Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient ...

4. urologytimes.com urologytimes.com/view/dean-elterman-md-shares-3-year-data-on-zenflow-spring-system-for-bph

Dean Elterman, MD, shares 3-year data on Zenflow Spring ... We saw an improvement in quality of life by at least 50%. We saw an improvement in urinary peak flows by over 30%. We saw a great responder rate ...

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/news/zenflow-spring-system-3-year-data-shows-durability-of-clinical-benefits-for-bph-patients/

Zenflow Spring System: 3-Year Data Shows Durability of ... Three years post-implantation, patients experienced a 46% improvement in IPSS scores, a key measure of BPH symptom severity. Quality of life ...

6. medicaldevice-network.com medicaldevice-network.com/news/zenflow-spring-system/

Zenflow announces Spring System data for BPH These studies showed that at the 36-month mark, individuals who received treatment with the Zenflow Spring exhibited a 46% improvement in their ...