- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03577236
The Zenflow Spring System EU Safety and Performance Study (ZEST EU)
July 15, 2021 updated by: Zenflow, Inc.
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A multi-center, prospective, single arm safety and performance trial.
Subjects will be treated either in the Investigator's out-patient treatment room or in the OR, with local anaesthesia only.
All subjects will be followed for the entire duration of the study until exit after the 60 month follow-up visit.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Debra Cogan, B.A., RN
- Phone Number: +001 408 515-0820
- Email: dcogan@zenflow.com
Study Contact Backup
- Name: Nicholas Damiano, MS
- Phone Number: +001 650 642-9658
- Email: Nick@zenflow.com
Study Locations
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New South Wales
-
Wahroonga, New South Wales, Australia, 2076
- Not yet recruiting
- Australian Clinical Trials
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Wollongong, New South Wales, Australia, 2500
- Recruiting
- South Coast Urology
-
Contact:
- Julie Edwards
- Phone Number: +61 612 4271 6644
- Email: nurse@southcoasturology.com.au
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Victoria
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Bendigo, Victoria, Australia, 3550
- Recruiting
- Goldfields Urology
-
Contact:
- Janelle Brennan, Miss, MD
- Phone Number: +61354413130
-
Contact:
- Janet Bennett, CRA
- Phone Number: +61354413130
- Email: janet_bennett@goldfieldsurology.com.au
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Melbourne, Victoria, Australia, 3050
- Recruiting
- Royal Melbourne Hospital
-
Contact:
- Richard Verrelli
- Phone Number: +61 613 9342 7348
- Email: richard.verrelli@mh.org.au
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Principal Investigator:
- Paul Anderson, MD
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-
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-
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Tauranga, New Zealand, 3140
- Recruiting
- Urology Bay of Plenty
-
Contact:
- Rana Reuther, CRA
- Phone Number: 64 7 577 7795
- Email: rana@urobop.co.nz
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Contact:
- Peter Gilling, MD
- Phone Number: 64 7 579 0466
- Email: peter@urobop.co.nz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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, and a baseline Quality of Life (QoL) question score > 3
- Prostate volume 25 - 80 cc by Trans Rectal Ultrasound (TRUS) or abdominal ultrasound, measured within past 90 days and prostatic urethral length between 2.5- 4.5 cm
- Failed, intolerant, or patient choice to not take a medication regimen for the treatment of LUTS
Patient must meet ONE of the following criteria:
- Baseline PSA <= 2.5ng/mL
- Baseline PSA >2.5 ng/mL and <=10 ng/mL AND free PSA >=25% of total PSA (no biopsy required or negative biopsy)
- Baseline PSA >10ng/mL AND negative prostate biopsy1 result within 12 months
- Negative prostate biopsy1 within 12 months if abnormal digital rectal examination
- 3 Tesla MRI of the prostate, with normal findings, within 12 months prior to the baseline visit
Exclusion Criteria:
- Obstructive intravesical median prostatic lobe which, in the opinion of the Investigator, 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:
- Peak urinary flow rate > 12 ml/second
- Post-void residual (PVR) > 250 ml
- Peak Urinary flow rate of > 15 ml/second
- < 125ml 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 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 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 unless evidence of same drug dose for at least 6 months with a stable voiding pattern (the drug dose should not be altered or discontinued throughout the study)
Taking one of the following within 2 weeks of pre-treatment (baseline) evaluation:
- alpha-blockers,
- androgens,
- anticholinergics, or
- cholinergic medication gonadotropin releasing hormonal analogs
Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- phenylephrine, or
- pseudoephedrine
- Future fertility concerns
- Any severe illness that might prevent study completion or would confound study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Zenflow Spring System
Receives treatment with the investigational device
|
The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful placement of the Zenflow Spring Implant
Time Frame: Day of discharge up to 7 days following device placement
|
Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
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Day of discharge up to 7 days following device placement
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Need for urinary catheterization
Time Frame: 7 days after the procedure
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Rate of extended post-operative urinary catheterization
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7 days after the procedure
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Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score and Quality of Life Score (IPSS+QoL)
Time Frame: Baseline and 3 months
|
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.
In addition the patient is asked 1 question related to his Quality of Life.
The possible responses range from 0 to 6 where 0 is the best and 6 is the worst.
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Adverse Events
Time Frame: Up to 2 years
|
Rate of adverse events related to the procedure or device.
|
Up to 2 years
|
Incidence of procedure or device related serious adverse events
Time Frame: Up to 30 days
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Assessment of any device or procedure related Serious Adverse Events (SAE)
|
Up to 30 days
|
Assessment of Sexual Health Assessment: Change in sexual health measured by change in the Sexual Health Inventory for Men (SHIM) questionnaire score
Time Frame: Baseline, 3, 6, 12, & 24 months
|
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 months
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Assessment of Sexual Health Assessment: Change in sexual health measured by change in ability to ejaculate using the Male Sexual Health Questionnaire - Ejaculatory domain (MSHQ-EjD)
Time Frame: Baseline, 3, 6, 12, & 24 months
|
The patient selects the most appropriate response to 4 questions about his sexual health specific to ejaculation.
Each response has an assigned value between 0 and 5.
|
Baseline, 3, 6, 12, & 24 months
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Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Time Frame: Baseline, 2 weeks, 1 month and 3 months
|
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.
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Baseline, 2 weeks, 1 month and 3 months
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Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time Frame: Baseline, 2 weeks, 1, 6, 12, 24 months
|
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.
In addition the patient is asked 1 question related to his Quality of Life.
The possible responses range from 0 to 6 where 0 is the best and 6 is the worst.
|
Baseline, 2 weeks, 1, 6, 12, 24 months
|
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time Frame: Baseline, 2 weeks, 1, 3, 6, 12, 24 months
|
Improvement in flow of urine as measured by uroflowmetry machine.
|
Baseline, 2 weeks, 1, 3, 6, 12, 24 months
|
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time Frame: Up to 2 years
|
Incidence of repeat invasive treatment for Lower Urinary Tract Symptoms (LUTS) or increase in dosage or initiation of new medication to treat symptoms of BPH.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 16, 2019
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
May 30, 2024
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
July 2, 2018
First Posted (ACTUAL)
July 5, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-0050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Benign Prostatic Hyperplasia
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St. Joseph's Healthcare HamiltonOntario Ministry of Health and Long Term CareCompletedBenign Prostatic HyperplasiaCanada
-
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Boston Scientific CorporationCompletedProstatic Hyperplasia | Benign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic, Czechia, Sweden
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Boston Scientific CorporationCompletedBenign Prostatic Hyperplasia | Prostatic Hyperplasia, Benign | Prostatic Hypertrophy | Prostatic Hypertrophy, Benign | Adenoma, Prostatic | Prostatic Adenoma | RezumDominican Republic
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IRCCS Policlinico S. MatteoCompletedBenign Prostatic Hyperplasia | Benign Prostatic Hypertrophy With Outflow ObstructionItaly
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-
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Clinical Trials on Zenflow Spring System
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Zenflow, Inc.UnknownBenign Prostatic HyperplasiaBulgaria, New Zealand
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Rodney A. White, M.D.CompletedAbdominal Aortic AneurysmsUnited States
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-
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