Evaluating the Zenflow Spring System for treating urinary symptoms from prostate enlargement

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

This study is testing a new device called the Zenflow Spring System to see if it can help men over 45 with urinary problems caused by prostate enlargement feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 45 Years and up
• Sex: Male
• Sponsor: Zenflow, Inc. (Industry-sponsored)
• Locations: 2 sites (Toronto, ONT and 1 other locations)
• Trial ID: NCT04309695 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the safety and performance of the Zenflow Spring System in alleviating symptoms associated with obstructive Benign Prostatic Hyperplasia (BPH). The study will involve patients aged 45 and older who have experienced significant lower urinary tract symptoms due to bladder outlet obstruction. Participants will receive the Zenflow Spring System as a minimally invasive treatment option, with the goal of providing effective symptom relief with minimal side effects. The trial will monitor patient outcomes and satisfaction to determine the system's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are men aged 45 and older with moderate to severe urinary symptoms due to BPH who have not found relief from medication.

Not a fit: Patients with certain urinary tract obstructions or prostate cancer may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could offer a safe and effective alternative for managing urinary symptoms in men with BPH.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in using minimally invasive techniques for BPH treatment.

Eligibility criteria

Inclusion Criteria:

1. Patient is able and willing to comply with all the assessments of the study
2. 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
3. ≥ 45 years of age
4. Baseline IPSS score \> 13
5. Prostate volume 25 - 80 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days
6. Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS

Exclusion Criteria:

1. Obstructive intravesical median prostatic lobe which in the opinion of the operator would not benefit from treatment
2. Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilations as reported in the patient's history
3. Requiring self-catheterization to void.
4. Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer
5. Any of the following, taken from a single uroflowmetry reading:

   1. Post-void residual volume (PVR) \> 250 ml
   2. Peak urinary flow rate of \> 15 ml/second
   3. \< 125 ml urinary volume voided at baseline (pre-bladder urinary volume of ≥150 ml required)
6. Other condition or disease that might cause urinary retention
7. History of other diseases causing voiding dysfunction
8. 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)
9. Concomitant bladder stones
10. Previous pelvic irradiation or radical pelvic surgery
11. Previous prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate
12. Chronic prostatitis, or recurring prostatitis within the past 12 months
13. Known allergy to nickel
14. Life expectancy less than 24 months
15. Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function
16. 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).
17. Taking 5-alpha-reductase inhibitors within 3 months of pre-treatment (baseline) evaluation
18. Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:

    1. alpha-blockers,
    2. imipramine,
    3. anticholinergics, or
    4. cholinergic medication gonadotropin releasing hormonal analogs
19. Taking androgens, unless evidence of eugonadal state for at least 6 months.
20. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:

    1. phenylephrine, or
    2. pseudoephedrine
21. Future fertility concerns
22. Any concurrent medical condition or illness that might prevent study completion or would confound study results

Where this trial is running

Toronto, ONT and 1 other locations

• Toronto Western Hospital — Toronto, Ont, Canada (Recruiting)
• Groupe Sante Brunswick — Pointe-Claire, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Emily Hu

Conditions Benign Prostatic Hyperplasia