Status:
UNKNOWN
The Zenflow Spring System Safety and Performance Study (ZEST CAN)
Lead Sponsor:
Zenflow, Inc.
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
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
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 du...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04309695
Start Date
February 9 2021
End Date
January 1 2026
Last Update
July 19 2021
Active Locations (2)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
2
Groupe Sante Brunswick
Pointe-Claire, Quebec, Canada, H9R 5K3