Benign Prostatic HyperplasiaZEST EUNCT03577236
The Zenflow Spring System EU Safety and Performance Study
A study testing Zenflow Spring System in people with Benign Prostatic Hyperplasia, run by Zenflow, Inc. at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Zenflow Spring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 16 Jan 2019to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Australia4 sites, 4 recruiting
- Recruiting
Goldfields Urology
Bendigo, Victoria, 3550
Janelle Brennan, Miss, MD, +61354413130
Janet Bennett, CRA, +61354413130, janet_bennett@goldfieldsurology.com.au
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Richard Verrelli, +61 613 9342 7348, richard.verrelli@mh.org.au
Paul Anderson, MD
- Not yet recruiting
Australian Clinical Trials
Wahroonga, New South Wales, 2076
Penny Ombler, +61 2 9473 8765, research@urologist.net.au
Henry Woo, MD
- Recruiting
South Coast Urology
Wollongong, New South Wales, 2500
Julie Edwards, +61 612 4271 6644, nurse@southcoasturology.com.au
Peter Chin, MD
New Zealand1 site, 1 recruiting
- Recruiting
Urology Bay of Plenty
Tauranga, 3140
Rana Reuther, CRA, 64 7 577 7795, rana@urobop.co.nz
Peter Gilling, MD, 64 7 579 0466, peter@urobop.co.nz
About this study
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).
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Zenflow Spring System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenflow Spring SystemDevice
Also called Spring Implant
The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
| Study group | Role | What they receive |
|---|---|---|
| Zenflow Spring System | Experimental | Receives treatment with the investigational device Receives: Device: Zenflow Spring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for urinary catheterization
Rate of extended post-operative urinary catheterization
Measured: 7 days after the procedure
Successful placement of the Zenflow Spring Implant
Successful deployment and procedural success for the Zenflow System to implant the Spring device in the operating room or an out-patient clinical setting.
Measured: 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 and Quality of Life Score (IPSS+QoL)
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.
Measured: Baseline and 3 months
Secondary outcomes (8)
Incidence of procedure or device related serious adverse events
Assessment of any device or procedure related Serious Adverse Events (SAE)
Measured: 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
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.
Measured: Baseline, 3, 6, 12, & 24 months
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)
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.
Measured: Baseline, 3, 6, 12, & 24 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.
Measured: Baseline, 2 weeks, 1 month and 3 months
Assessment of Adverse Events
Rate of adverse events related to the procedure or device.
Measured: Up to 2 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. 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.
Measured: Baseline, 2 weeks, 1, 6, 12, 24 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Improvement in flow of urine as measured by uroflowmetry machine.
Measured: Baseline, 2 weeks, 1, 3, 6, 12, 24 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start16 Jan 2019
- Primary completionDec 2022 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-center, prospective, single-arm.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenflow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Gilling, MD, Principal investigator, Tauranga Urology Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577236
- Sponsor's protocol ID
- CLIN-0050
- Acronym
- ZEST EU
- Status last verified
- Jul 2021
- First submitted
- 16 May 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gilling P, Chin P, Anderson P, Zorn K, Matsumoto ED, Lynch W, Chan L, Woo H, Perez Becerra R, Brennan J, Elterman D. Zenflow spring system for benign prostatic hyperplasia - 24 month outcomes of the ZEST pilot studies. Prostate Cancer Prostatic Dis. 2026 Jun 9. doi: 10.1038/s41391-026-01126-3. Online ahead of print.
PubMed 42265447
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Zenflow Spring System EU Safety and Performance Study
- ClinicalTrials.gov ID
- NCT03577236
- Acronym / sponsor ID
- ZEST EU / CLIN-0050
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zenflow, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center, prospective, single-arm.
| Arm | Type | Receives |
|---|---|---|
| Zenflow Spring System | Experimental | Device: Zenflow Spring SystemReceives treatment with the investigational device |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (31 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenflow Spring SystemAlso: Spring ImplantThe Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool. | Device | Zenflow Spring System |
Primary outcome
Need for urinary catheterization
Time frame: 7 days after the procedure
Rate of extended post-operative urinary catheterization
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.
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.
8 secondary outcomes
Incidence of procedure or device related serious adverse events
Time frame: 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
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
Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Time frame: Baseline, 2 weeks, 1 month and 3 months
Assessment of Adverse Events
Time frame: Up to 2 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time frame: 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
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 42265447Gilling P, Chin P, Anderson P, Zorn K, Matsumoto ED, Lynch W, Chan L, Woo H, Perez Becerra R, Brennan J, Elterman D. Zenflow spring system for benign prostatic hyperplasia - 24 month outcomes of the ZEST pilot studies. Prostate Cancer Prostatic Dis. 2026 Jun 9. doi: 10.1038/s41391-026-01126-3. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Benign Prostatic Hyperplasia
Not yet recruitingPhase 3
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Gilling, MD principal investigator
Tauranga Urology Research Ltd.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zenflow Spring System in people with Benign Prostatic Hyperplasia, run by Zenflow, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debra Cogan, B.A., RN (+001 408 515-0820, dcogan@zenflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for urinary catheterization (time frame: 7 days after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.