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Implantable Device
Zenflow Spring System for Benign Prostatic Hyperplasia (BREEZE Trial)
N/A
Recruiting
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
Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post procedure through 24 months post procedure
Awards & highlights
BREEZE Trial Summary
This trial will evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with 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.Check my eligibility
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.See study design
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.
BREEZE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate urethra length is between 25 and 45 mm.
Select...
I have tried and cannot tolerate medication for urinary symptoms, or I chose not to take them.
Select...
I am 45 years old or older.
BREEZE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post procedure through 24 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post procedure through 24 months post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Effectiveness - Re-intervention (device)
Effectiveness - Re-intervention (drug)
Effectiveness - flow metrics
+8 moreBREEZE 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate urethra length is between 25 and 45 mm.I have taken medication for prostate enlargement within the last 3 months.You are not expected to live for at least 5 years.I have tried and cannot tolerate medication for urinary symptoms, or I chose not to take them.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.I have had chronic prostatitis, CPPS, or painful bladder syndrome in the last year.You are allergic to nickel.I have bladder stones along with my current condition.I have taken phenylephrine or pseudoephedrine within the last 24 hours.Your prostate size is between 25 and 80 cc, as measured by a transrectal ultrasound within 120 days of agreeing to join the study.I am 45 years old or older.You need a tube or a special method to empty your bladder.I am taking medication that affects bladder function.I have tried and cannot tolerate medication for urinary symptoms, or I choose not to take them.My ultrasound shows a significant prostate enlargement into the bladder.The way your bladder connects to other parts of your body suggests you might have a condition called primary bladder neck obstruction, as determined by the study doctor.I have or had a narrowed urethra or bladder neck.Your anatomy is not suitable for the implant based on a cystoscopy examination.My PSA level is above 10 ng/mL, or I am suspected to have prostate cancer.I have a condition like diabetes or MS that affects my bladder control.I have an overactive bladder without prostate issues.I do not currently have a UTI, or if I did, it has been treated and cleared.I have had radiation or major surgery in my pelvic area before.I have had surgery on my prostate before.I cannot stop my blood thinners for 3 days, or coumadin for 5 days, before a procedure.I have been taking specific medications for bladder or prostate issues, or hormone therapy.Concerns about having children in the futureThe subject is able and willing to comply with all the assessments of the study.Your IPSS score is 13 or higher, and your IPSS voiding to storage sub-score ratio is at least 1.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Treatment Arm
- Group 3: Crossover Cohort
- Group 4: Roll-in Cohort
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Benign Prostatic Hyperplasia Patient Testimony for trial: Trial Name: NCT04987138 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there multiple research centers executing this clinical trial across the United States?
"6 different medical centres are participating in this research, such as Urology of Virginia, PLLC stationed in Virginia Beach and American Institute of Research situated in Los Angeles. Carolina Urologic Research Associates is also recruiting patients from Myrtle Beach alongside 3 other sites."
Answered by AI
Is the recruitment process ongoing for this experiment?
"Yes, latest data from clinicaltrials.gov confirms that this trial has been actively recruiting since its initial posting on September 30th 2021 and is presently in need of 279 participants to be enrolled across 6 medical centres."
Answered by AI
Could you provide the overall figure of participants involved in this medical trial?
"Indeed, from the information posted on clinicaltrials.gov it is evident that this medical trial is still ongoing and actively seeking patients since its initiation back in September of 2021. The study demands 279 individuals to be recruited across 6 different locations."
Answered by AI
What outcomes is the trial hoping to accomplish?
"This medical experiment, which will be assessed over a three-month timeframe, strives to reduce the need for catheterization. Secondary endpoints of this study are efficacy measured by percentage of patients who note at least 30% improvement in IPSS scores from pre-treatment baseline; safety associated with device removal and pain levels as indicated by Visual Analogue Scale (VAS) questionnaire results taken both upon discharge and during follow up visits 2 weeks later, 1 month after that, and then 3 months post intervention. VAS uses a scale ranging from one signifying no discomfort to ten denoting worst possible agony."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Colorado
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Urology Austin, PLLC
Sheldon Freedman, MD, LTD
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have tried drugs and supplements and nothing is satisfactory. I’ve tried many many many drugs and physical therapy for years and one time a trial experimentally PRP is the only thing that helped.
PatientReceived no prior treatments
I am evaluating different possible treatments for BPH. I don't want to rely on medications. I have looked at Rezum and Aquablation as possible treatments, but I am also curious about emerging new treatments such as the one you're evaluating, I did a search and found that this clinical trial is being conducted locally, so I am interested in being considered as a candidate.
PatientReceived no prior treatments
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