Benign Prostatic HyperplasiaNCT04309695
The Zenflow Spring System Safety and Performance Study (ZEST CAN)
A study testing Zenflow Spring System in people with Benign Prostatic Hyperplasia, run by Zenflow, Inc. at 2 sites in Canada.
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
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 9 Feb 2021to 1 Jan 2026
- 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
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Groupe Sante Brunswick
Pointe-Claire, Quebec, H9R 5K3
Michele Tisseur, RN, 514-823-5018
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Iris Chan, 416 603 5800 ext. 5033, iris.chan2@uhn.ca
Dean Elterman, MD, MSc, FRCSC
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
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.
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Receives intervention with the Zenflow Spring System. Receives: Device: Zenflow Spring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
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.
Measured: 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.
Measured: 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.
Measured: 30 days after the procedure
Secondary outcomes (9)
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, 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Assessment of PSA
Change in PSA from baseline through 12, 24, 36, 48, \& 60 months post treatment.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Incidence of repeat treatment.
Measured: 24 to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start9 Feb 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenflow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309695
- Sponsor's protocol ID
- CLIN-0111
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2020
- Last updated
- 19 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 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Zenflow Spring System Safety and Performance Study (ZEST CAN)
- ClinicalTrials.gov ID
- NCT04309695
- Acronym / sponsor ID
- CLIN-0111
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zenflow, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 Mar 2020 (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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Zenflow Spring SystemReceives intervention with the Zenflow Spring System. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- Prostate volume 25 - 80 cc and prostatic urethral length between 2.5-4.5 cm measured within the past 90 days
Key exclusion criteria (31 listed)
- 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:
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 SystemThe 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. | Device | Treatment Group |
Primary outcome
Successful placement of the Zenflow Spring Implant
Time frame: Day of discharge up to 7 days following device placement
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.
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) using the International Prostate Symptom Score
Time frame: 3 month
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.
Need for urinary catheterization
Time frame: 7 days after the procedure
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.
Incidence of procedure or device related serious adverse events
Time frame: 30 days after the procedure
Achieve < 12% rate of device or procedure related SAEs through discharge and 30 days follow up.
9 secondary outcomes
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, 36, 48, & 60 months
Assessment of Pain, evaluated using a Visual Analog Score (VAS) of 1 to 10
Time frame: Baseline, interoperative (if conscious sedation used), immediately post-treatment, 2 weeks, 1 and 3 months
Assessment of Adverse Events
Time frame: Up to 5 years
Assessment of Clavien-Dindo events
Time frame: Up to 5 years
Assessment of PSA
Time frame: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time frame: Baseline, 2 weeks, 1, 6, 12, 24, 36, 48, & 60 months
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time frame: 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)
Time frame: Up to 5 years
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH)
Time frame: 24 to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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 recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
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Urinary Urge Incontinence, Stress Urinary Incontinence
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Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
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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.
2 sites in 1 country: 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 2 sites in Canada.
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 6 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 19 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 2 sites in Canada. 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 Emily Hu (5109098237, emily@zenflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful placement of the Zenflow Spring Implant (time frame: Day of discharge up to 7 days following device placement). The study lists 4 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 NCT04309695, 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 19 Jul 2021.