BPH (Benign Prostatic Hyperplasia)BREEZENCT04987138
Safety and Effectiveness Study of the Zenflow Spring System
A study testing Zenflow Spring System in people with BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), run by Zenflow, Inc. at 7 sites in United States.
Trial summary
Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- Zenflow Spring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Sep 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able and willing to comply with all the assessments of the study,
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form,
- ≥ 45 years of age,
- Baseline IPSS score ≥ 13; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S),
- Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent,
- 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.
Who cannot join
- Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound),
- High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
- Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
- Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
- Requires indwelling catheter or intermittent catheterization to void,
- Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction),
Show all 35Show fewer
- One of the following baseline test results, taken from a single uroflowmetry reading:
- Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
- Peak urinary flow rate (Qmax) of ≤ 5 ml/second or > 15 mL/second,
- Post- void residual volume (PVR) > 250 mL
- History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
- Subjects with overactive bladder in the absence of benign prostatic obstruction,
- Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated and followed with a negative urine test result), or subjects with history of recurrent UTIs (defined as > 3 UTIs in the past 12 months),
- Concomitant bladder stones,
- Previous pelvic irradiation or radical pelvic surgery,
- Previous prostate surgery, including: enucleation, resection, vaporization, thermotherapy, ablation, stenting or prostatic urethral lift,
- Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
- Known allergy to nickel,
- Life expectancy less than 60 months,
- Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function,
- Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy (81 mg) is permitted),
- Taking 5-alpha-reductase inhibitors within 3 months of baseline evaluation,
- Taking one of the following within 2 weeks of baseline evaluation:
- alpha-blockers,
- imipramine,
- anticholinergics,
- cholinergic gonadotropin releasing hormonal analogues,
- Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,
- Beta-3 adrenergic receptor agonist (Mirabegron),
- Taking androgens, unless eugonadal state for at least 3 months or greater as documented by the Investigator,
- Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- phenylephrine, or,
- pseudoephedrine,
- Future fertility concerns, or,
- In the Investigator's opinion, the subject has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Midtown Urology Associates
Austin, Texas, 78705
Urology Austin, PLLC
Austin, Texas, 78745
Northshore University Health System
Glenview, Illinois, 60026
Sheldon Freedman, MD, LTD
Las Vegas, Nevada, 89144
American Institute of Research
Los Angeles, California, 90017
Carolina Urologic Research Associates
Myrtle Beach, South Carolina, 29572
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462
About this study
Official title: Safety and Effectiveness Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.
Read the detailed description
Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System.
Patients randomized to the treatment group will undergo Zenflow Spring placement.
Patients randomized to the control group will undergo a Sham procedure. Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit. Once a patient has completed their 3-month follow-up assessments, they will be unblinded. Following unblinding, patients who received a Sham procedure may elect to receive treatment with the Zenflow Spring System or alternatively they may exit the study.
The duration of study participation is 60 months for patients who receive a Spring Implant and 3 months for subjects in the Control Arm.
- Being tested
- Zenflow Spring System, Sham Procedure
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenflow Spring SystemDevice
The Zenflow Spring Implant is an electropolished and passivated nickel titanium alloy (nitinol) implant. The implant is constructed from a single wire strand formed into ring elements connected by spine sections. There are four sizes of implants ranging from 16 mm to 24 mm in length and 14 mm to 16 mm in diameter to implant in the subject's prostatic urethra. The implant is placed in the urethra using a custom delivery catheter and cystoscope (Spring Scope). The implant is intended to be permanent but can be removed if necessary.
Sham ProcedureDevice
Also called Foley Catheter
A18 Fr Foley Catheter is placed into the patient's bladder. To mimic the Treatment Arm procedure, the Foley Catheter balloon will be inflated in the bladder. Once inflated, slight tension will be applied against the subject's bladder neck. While tension is being applied the site staff will follow a script to simulate the Zenflow procedural steps. 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.
| Study group | Role | What they receive |
|---|---|---|
| Roll-in Cohort | Other | 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. Receives: Device: Zenflow Spring System |
| Treatment Arm | Active comparator | 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. Receives: Device: Zenflow Spring System |
| Control Arm | Sham comparator | 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. Receives: Device: Sham Procedure |
| Crossover Cohort | Other | 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. Receives: Device: Zenflow Spring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - The need for urinary catheterization
The rate of extended post-operative urinary catheterization (> 7 days from treatment) for inability to void among patients treated with the Zenflow Spring System.
Measured: Greater than 7 days after procedure
Safety - Adverse Events
The rate of device or procedure related serious adverse events in both the Treatment Arm and the Sham Arm.
Measured: Procedure through 12 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
The Treatment Arm will be considered superior to the Control Arm (Sham) when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Control Arm (Sham) alone.
Measured: Procedure to 3 months
Effectiveness- Symptoms Improvement
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the Patient's pre-treatment baseline score.
Measured: Procedure to 12 months
Secondary outcomes (11)
Safety - Adverse Events
Rate of device or procedure related adverse events at all time points.
Measured: Procedure through 60 months
Safety - Pain Assessment Questionnaire
Comparison of pain at discharge to 2-week, 1- and, 3-month follow-up visits per Visual Analogue Scale (VAS) questionnaire. The VAS questionnaire asks the patient to indicate on a scale of 1 to 10 his level of pain where 1 is no pain and 10 is the worst pain.
Measured: Procedure through 3 months
Safety - Sexual Health Questionnaire 1
Change in sexual health characterized by the questionnaire Sexual Health Inventory for Men (SHIM).
Measured: 3 months post procedure through 24 months post procedure
Safety - Sexual Health Questionnaire 2
Change in sexual health characterized by questionnaire Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD)
Measured: 3 months post procedure through 24 months post procedure
Safety - Device Removal
Assessment of adverse events outcomes related to a Spring Implant removal procedure.
Measured: Procedure through 60 months
Safety - Classification of Adverse Events
Proportion of patients with adverse events classified as Clavien-Dindo Grade IIIb or higher or any event resulting in persistent disability
Measured: Procedure through 3 months
Effectiveness - long term symptom improvement 1
Percent of patients who experience at least a 30 percent improvement in IPSS from their baseline pre-treatment score
Measured: Procedure through 12 months
Effectiveness - long term symptom improvement 2
Mean percent change in IPSS in the treatment arm compared to baseline at all timepoints other than the primary endpoints.
Measured: Procedure through 60 months
Effectiveness - flow metrics
Change from baseline in uroflowmetry measures of peak flow rate (Qmax)
Measured: 1 month post procedure through 60 months
Effectiveness - Re-intervention (device)
Post-procedure incidence of secondary reintervention using an alternate surgical LUTS therapy.
Measured: Procedure through 60 months
Effectiveness - Re-intervention (drug)
Post-procedure incidence of secondary reintervention using standard pharmacological agents for LUTS therapy.
Measured: Procedure through 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start30 Sep 2021
- Primary completion30 Jun 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System. Following unblinding, control patients may elect to receive treatment with the Zenflow Spring System or exit the study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenflow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Roehrborn, M.D, Principal investigator, UT Southwestern, Dallas, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987138
- Sponsor's protocol ID
- CLIN-0130
- Acronym
- BREEZE
- Status last verified
- Apr 2024
- First submitted
- 13 Jul 2021
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
- ClinicalTrials.gov ID
- NCT04987138
- Acronym / sponsor ID
- BREEZE / CLIN-0130
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Zenflow, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.
Detailed description
Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System.
Patients randomized to the treatment group will undergo Zenflow Spring placement.
Patients randomized to the control group will undergo a Sham procedure. Patients and site personnel administering follow-up assessments will be blinded to the randomized treatment through completion of the 3-month follow-up visit. Once a patient has completed their 3-month follow-up assessments, they will be unblinded. Following unblinding, patients who received a Sham procedure may elect to receive treatment with the Zenflow Spring System or alternatively they may exit the study.
The duration of study participation is 60 months for patients who receive a Spring Implant and 3 months for subjects in the Control Arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective, multi-center, multinational, 2:1 randomized, single-blinded, controlled clinical trial of the Zenflow Spring System. Following unblinding, control patients may elect to receive treatment with the Zenflow Spring System or exit the study.
| Arm | Type | Receives |
|---|---|---|
| Roll-in Cohort | Other | Device: Zenflow Spring SystemEach 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. |
| Treatment Arm | Active comparator | Device: Zenflow Spring SystemIncludes 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. |
| Control Arm | Sham comparator | Device: Sham ProcedureIncludes 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. |
| Crossover Cohort | Other | Device: Zenflow Spring SystemControl 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is able and willing to comply with all the assessments of the study,
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the informed consent form,
- ≥ 45 years of age,
- Baseline IPSS score ≥ 13; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S),
- Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent,
Key exclusion criteria (35 listed)
- Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound),
- High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
- Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
- Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
- Requires indwelling catheter or intermittent catheterization to void,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenflow Spring SystemThe Zenflow Spring Implant is an electropolished and passivated nickel titanium alloy (nitinol) implant. The implant is constructed from a single wire strand formed into ring elements connected by spine sections. There are four sizes of implants ranging from 16 mm to 24 mm in length and 14 mm to 16 mm in diameter to implant in the subject's prostatic urethra. The implant is placed in the urethra using a custom delivery catheter and cystoscope (Spring Scope). The implant is intended to be permanent but can be removed if necessary. | Device | Crossover Cohort, Roll-in Cohort, Treatment Arm |
| Sham ProcedureAlso: Foley CatheterA18 Fr Foley Catheter is placed into the patient's bladder. To mimic the Treatment Arm procedure, the Foley Catheter balloon will be inflated in the bladder. Once inflated, slight tension will be applied against the subject's bladder neck. While tension is being applied the site staff will follow a script to simulate the Zenflow procedural steps. 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. | Device | Control Arm |
Primary outcome
Safety - The need for urinary catheterization
Time frame: Greater than 7 days after procedure
The rate of extended post-operative urinary catheterization (> 7 days from treatment) for inability to void among patients treated with the Zenflow Spring System.
Safety - Adverse Events
Time frame: Procedure through 12 months
The rate of device or procedure related serious adverse events in both the Treatment Arm and the Sham Arm.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) as compared to Sham
Time frame: Procedure to 3 months
The Treatment Arm will be considered superior to the Control Arm (Sham) when the mean 3-month improvement from baseline score for the IPSS symptom questionnaire demonstrates a minimum statistical margin of 25% compared to mean improvement from baseline for the Control Arm (Sham) alone.
Effectiveness- Symptoms Improvement
Time frame: Procedure to 12 months
The mean percent change in IPSS in the treatment arm is at least 30% improvement over the Patient's pre-treatment baseline score.
11 secondary outcomes
Safety - Adverse Events
Time frame: Procedure through 60 months
Safety - Pain Assessment Questionnaire
Time frame: Procedure through 3 months
Safety - Sexual Health Questionnaire 1
Time frame: 3 months post procedure through 24 months post procedure
Safety - Sexual Health Questionnaire 2
Time frame: 3 months post procedure through 24 months post procedure
Safety - Device Removal
Time frame: Procedure through 60 months
Safety - Classification of Adverse Events
Time frame: Procedure through 3 months
Effectiveness - long term symptom improvement 1
Time frame: Procedure through 12 months
Effectiveness - long term symptom improvement 2
Time frame: Procedure through 60 months
Effectiveness - flow metrics
Time frame: 1 month post procedure through 60 months
Effectiveness - Re-intervention (device)
Time frame: Procedure through 60 months
Effectiveness - Re-intervention (drug)
Time frame: Procedure through 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus Roehrborn, M.D principal investigator
UT Southwestern, Dallas, TX
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenflow Spring System in people with BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), run by Zenflow, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - The need for urinary catheterization (time frame: Greater than 7 days after procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.