The Zenflow Spring System Safety and Performance Study (ZEST CAN)

Study Overview
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Brief Summary
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The objectives of the trial are to demonstrate the safety and performance of the Zenflow Spring System in relieving the symptoms of obstructive Benign Prostatic Hyperplasia (BPH).

Detailed Description
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The purpose of the Zenflow Study (ZEST CAN) is to evaluate the safety, performance and effectiveness of the Zenflow Spring System for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hyperplasia (BPH). It is intended that the features of the Zenflow Spring will provide an effective office-based treatment and management therapy for BPH with little or no side effects.

Official Title
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The Zenflow Spring System Safety and Performance Study (ZEST CAN)

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Zenflow Spring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is able and willing to comply with all the assessments of the study Patient or patient'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 Prostate volume 25 - 80 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS Exclusion Criteria: Obstructive intravesical median prostatic lobe which in the opinion of the operator would not benefit from treatment Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilations as reported in the patient's history Requiring self-catheterization to void. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer Any of the following, taken from a single uroflowmetry reading: Post-void residual volume (PVR) > 250 ml Peak urinary flow rate of > 15 ml/second < 125 ml urinary volume voided at baseline (pre-bladder urinary volume of ≥150 ml required) Other condition or disease that might cause urinary retention History of other diseases causing voiding dysfunction Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months) Concomitant bladder stones Previous pelvic irradiation or radical pelvic surgery Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate Chronic prostatitis, or recurring prostatitis within the past 12 months Known allergy to nickel Life expectancy less than 24 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 (low dose aspirin therapy not prohibited). Taking 5-alpha-reductase inhibitors within 3 months of pre-treatment (baseline) evaluation Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation: alpha-blockers, imipramine, anticholinergics, or cholinergic medication gonadotropin releasing hormonal analogs Taking androgens, unless evidence of eugonadal state for at least 6 months. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation: phenylephrine, or pseudoephedrine Future fertility concerns Any concurrent medical condition or illness that might prevent study completion or would confound study results

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Receives intervention with the Zenflow Spring System. | Device: Zenflow Spring System<br>* The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful placement of the Zenflow Spring Implant | Number of successful deployments and procedural successes for the Zenflow System to implant the Spring device in the OR, or in an out-patient clinical setting as compared to total treatment attempts. | Day of discharge up to 7 days following device placement | 
| Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score | At 3 months, achieve at least 30% mean improvement in International Prostate Symptom Score (IPSS) compared to baseline. The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total IPSS score. | 3 month | 
| Need for urinary catheterization | Achieve < 12% rate of extended post-operative urinary catheterization, defined as an occurrence of a subject requiring catheterization within the first 3 days as part of a postoperative management for inability to void, for greater than 7 days. | 7 days after the procedure | 
| Incidence of procedure or device related serious adverse events | Achieve < 12% rate of device or procedure related SAEs through discharge and 30 days follow up. | 30 days after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score | The patient selects the most appropriate response to 5 questions about his sexual health. Each response has an assigned value between 1 and 5. The numeric values are tallied for a total score. | Baseline, 3, 6, 12, 24, 36, 48, & 60 months | 
| Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10 | Patient describes pain on a Visual Analog Scale (VAS). The scale is a line labeled 1 at the far left indicating minimal pain and 10 on the right, which is maximum pain. | Baseline, interoperative (if conscious sedation used), immediately post-treatment, 2 weeks, 1 and 3 months | 
| Assessment of Adverse Events | Rate of adverse events related to the procedure or device. | Up to 5 years | 
| Assessment of Clavien-Dindo events | Proportion of subjects with procedure or device related adverse events classified as Clavien-Dindo Grade 3 or higher or any event resulting in persistent disability evidenced through 3 months post treatment. | Up to 5 years | 
| Assessment of PSA | Change in PSA from baseline through 12, 24, 36, 48, & 60 months post treatment. | Up to 5 years | 
| Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) | The patient is asked to respond to 7 questions related to his urinary health using a rating scale of 0 to 5 where zero is excellent and 5 is the worst possible. The responses to the 7 questions are tallied for a total score | Baseline, 2 weeks, 1, 6, 12, 24, 36, 48, & 60 months | 
| Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) | Improvement in flow of urine as measured by uroflowmetry machine. | Baseline, 2 weeks, 1, 3, 6, 12, 24, 36, 48, & 60 months | 
| Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) | Incidence of increase in dosage or initiation of new medication to treat symptoms of BPH. | Up to 5 years | 
| Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) | Incidence of repeat treatment. | 24 to 60 months |