Safety and Effectiveness Study of the Zenflow Spring System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2026-06-30

Brief Summary

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Evaluate the safety and effectiveness of the Zenflow Spring System in relieving LUTS associated with BPH.

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Detailed Description

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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.

Conditions

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BPH (Benign Prostatic Hyperplasia) Lower Urinary Tract Symptoms (LUTS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The patient and site personnel administering follow-up assessments to 3 months will be blinded to the study assignment. Unblinding will occur at 3 months post procedure after follow-up assessments are completed.

All patients will be asked post-treatment if they believe they are in the Treatment Arm, Control Arm, or do not know. The blinding questionnaire will be administered at discharge and at the 1-month and 3-month follow-up assessments.

Control Arm patients can receive treatment with the Zenflow Spring System within 30 days after their 3-month follow-up assessments are completed, and their symptoms warrant treatment and enrollment criteria are met.

Study Groups

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Roll-in Cohort

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 Type OTHER

Zenflow Spring System

Intervention Type DEVICE

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.

Treatment Arm

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 Type ACTIVE_COMPARATOR

Zenflow Spring System

Intervention Type DEVICE

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.

Control Arm

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.

Group Type SHAM_COMPARATOR

Sham Procedure

Intervention Type DEVICE

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.

Crossover Cohort

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 Type OTHER

Zenflow Spring System

Intervention Type DEVICE

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.

Interventions

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Zenflow Spring System

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.

Intervention Type DEVICE

Sham Procedure

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.

Intervention Type DEVICE

Other Intervention Names

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Foley Catheter

Eligibility Criteria

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Inclusion Criteria

1. Subject is able and willing to comply with all the assessments of the study,
2. 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,
3. ≥ 45 years of age,
4. Baseline IPSS score ≥ 13; ≥ 1 in the IPSS voiding to storage sub-score ratio (IPSS-V/S),
5. Prostate volume 25 - 80 cc by transrectal ultrasound (TRUS), measured within 120 days post study consent,
6. Prostatic urethral length between 25 and 45 mm, as measured by cystoscopic pull-back,
7. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

Exclusion Criteria

1. 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),
2. High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
3. Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
4. Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
5. Requires indwelling catheter or intermittent catheterization to void,
6. 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),
7. One of the following baseline test results, taken from a single uroflowmetry reading:

1. Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
2. Peak urinary flow rate (Qmax) of ≤ 5 ml/second or \> 15 mL/second,
3. Post- void residual volume (PVR) \> 250 mL
8. History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
9. Subjects with overactive bladder in the absence of benign prostatic obstruction,
10. 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),
11. Concomitant bladder stones,
12. Previous pelvic irradiation or radical pelvic surgery,
13. Previous prostate surgery, including: enucleation, resection, vaporization, thermotherapy, ablation, stenting or prostatic urethral lift,
14. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
15. Known allergy to nickel,
16. Life expectancy less than 60 months,
17. Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function,
18. 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),
19. Taking 5-alpha-reductase inhibitors within 3 months of baseline evaluation,
20. Taking one of the following within 2 weeks of baseline evaluation:

1. alpha-blockers,
2. imipramine,
3. anticholinergics,
4. cholinergic gonadotropin releasing hormonal analogues,
5. Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,
6. Beta-3 adrenergic receptor agonist (Mirabegron),
21. Taking androgens, unless eugonadal state for at least 3 months or greater as documented by the Investigator,
22. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:

1. phenylephrine, or,
2. pseudoephedrine,
23. Future fertility concerns, or,
24. 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).

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No