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Implantable Device

Zenflow Spring System for Benign Prostatic Hyperplasia (BREEZE Trial)

N/A
Waitlist Available
Led By Claus Roehrborn, M.D
Research Sponsored by Zenflow, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back
≥ 45 years of age
Must not have
Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
Concomitant bladder stones
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post procedure through 24 months post procedure

Summary

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).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, possible reaction if allergic to nickel contained in the device, urinary tract infection risk increase post-procedure and potential need for re-treatment if symptom relief isn't achieved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate urethra length is between 25 and 45 mm.
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I am 45 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.
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I have bladder stones along with my current condition.
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My ultrasound shows a significant prostate enlargement into the bladder.
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I have or had a narrowed urethra or bladder neck.
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I have a condition like diabetes or MS that affects my bladder control.
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I have an overactive bladder without prostate issues.
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I have had radiation or major surgery in my pelvic area before.
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I have had surgery on my prostate before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post procedure through 24 months post procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post procedure through 24 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
Effectiveness- Symptoms Improvement
Safety - The need for urinary catheterization
Secondary study objectives
Effectiveness - Re-intervention (device)
Effectiveness - Re-intervention (drug)
Effectiveness - flow metrics
+8 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Benign Prostatic Hyperplasia (BPH) include alpha-1-adrenergic antagonists, 5-alpha reductase inhibitors, and mechanical interventions like the Prostatic Urethral Lift (PUL). Alpha-1-adrenergic antagonists work by relaxing the smooth muscles in the prostate and bladder neck, improving urine flow. 5-alpha reductase inhibitors reduce the size of the prostate by blocking the conversion of testosterone to dihydrotestosterone. Mechanical interventions, such as the PUL and the Zenflow Spring System, physically open the prostatic urethra to relieve obstruction. These treatments are crucial for BPH patients as they directly address the urinary obstruction, improving symptoms and quality of life.

Find a Location

Who is running the clinical trial?

Zenflow, Inc.Lead Sponsor
4 Previous Clinical Trials
160 Total Patients Enrolled
Claus Roehrborn, M.DPrincipal InvestigatorUT Southwestern, Dallas, TX

Media Library

Zenflow Spring System (Implantable Device) Clinical Trial Eligibility Overview. Trial Name: NCT04987138 — N/A
Enlarged prostate Research Study Groups: Control Arm, Treatment Arm, Crossover Cohort, Roll-in Cohort
Enlarged prostate Clinical Trial 2023: Zenflow Spring System Highlights & Side Effects. Trial Name: NCT04987138 — N/A
Zenflow Spring System (Implantable Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04987138 — N/A
Enlarged prostate Patient Testimony for trial: Trial Name: NCT04987138 — N/A
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