Benign Prostatic HyperplasiaZEST2NCT03595735
The Zenflow Spring System Safety, Performance and Effectiveness Study
A study testing Zenflow Spring System in people with Benign Prostatic Hyperplasia, run by Zenflow, Inc. at 3 sites in Mexico.
Trial summary
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve 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
- 3 sitesMexico
- Study dates
- 21 Jun 2018to 30 Mar 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
- All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥ 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), measured within past 90 days and prostatic urethral length between 2.5-4.5 cm.
- Failed or intolerant to medication regimen for the treatment of LUTS.
Who cannot join
- Subjects will be excluded from participating in this trial if they meet any of the following criteria:
- Obstructive intravesical median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
- Elevated risk of prostate cancer
- Post-void residual volume (PVR) > 250 ml
Show all 25Show fewer
- Peak urinary flow rate > 12 ml/second, with ≥ 125 ml voided volume at baseline
- History of chronic urinary retention
- History of neurogenic bladder
- Compromised renal function (e.g., serum creatinine > 1.8 mg/dl) due to bladder obstruction
- Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a clean urine test)
- Concomitant bladder stones
- Confirmed or suspected bladder cancer
- 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
- Serious concurrent medical conditions such as uncontrolled diabetes
- Known allergy to nickel
- Life expectancy less than 24 months
- Use of concomitant medications (e.g., anticholinergics, antispasmodics or antidepressants) affecting bladder function
- Patients taking coumadin 3 days or less prior to procedure and have INR value > 1.5 on day of procedure. ASA and clopidogrel must be ceased 7 days prior to the procedure
- 5 alpha reductase inhibitors within 6 months of pre-treatment 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 for entrance into or throughout the study)
- alpha blockers within 2 weeks of pre-treatment 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 for entrance into or throughout the study)
- Future fertility concerns
- Any severe illness that might prevent study completion or would confound study results
Trial locations and contacts
3 sites in 1 country.
Mexico3 sites
Hospital Universitario "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
Centro de Urología Avanzada del Noreste (CUAN)
Monterrey, Nuevo León, 66269
Hospital Regional de Alta Especialidad de Ixtapaluca
Zoquiapan, Ciudad de Ixtapaluca, 56530
About this study
Official title: The Zenflow Spring System Safety, Performance and Effectiveness Study (ZEST2)
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Read the detailed description
A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2.
Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpose of stage 1 is to assess acute safety and performance of the Zenflow System at the time of the procedure, through discharge, 2 weeks and 1 month, in up to 10 subjects enrolled at up to 7 investigational sites, to determine continuation to stage 2.
Upon successful completion of stage 1, the study will be expanded to stage 2 with sites added and continued enrollment in the ITT cohort. All subjects, including those enrolled in the stage 1 evaluation, will continue to be followed at all the designated follow-up time points for the full duration of the study (60 months).
Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (60 months), or until exited.
- 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 |
|---|---|---|
| Treatment Group | Experimental | Receives treatment 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
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
Need for urinary catheterization
Rate of extended post-operative urinary catheterization
Measured: 7 days after the procedure
Secondary outcomes (9)
Incidence of procedure or device related serious adverse events
Assessment of any device or procedure related Serious Adverse Events (SAE)
Measured: Day of discharge up to 7 days following device placement
Assessment of Pain
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
Assessment of Sexual Health: 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: 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
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score and Quality of Life Questionnaire (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 is 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
Measured: Baseline, 2 weeks, 1, 3, 6, 12, 24 months
Repeat interventions to treat 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
Increase or change in medications to treat Benign Prostatic Hyperplasia (BPH)
Incidence of 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 posted23 Jul 2018
- Study start21 Jun 2018
- Primary completion30 Dec 2020
- Study completion30 Mar 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zenflow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan J Galan, MD, Principal investigator, Centro de Urología Avanzada del Noreste (CUAN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595735
- Sponsor's protocol ID
- CLIN-0043
- Acronym
- ZEST2
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Safety, Performance and Effectiveness Study (ZEST2)
- ClinicalTrials.gov ID
- NCT03595735
- Acronym / sponsor ID
- ZEST2 / CLIN-0043
- 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
- 21 Jun 2018 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 23 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.
This is a clinical evaluation to assess the safety and performance of the Zenflow Spring System when used as intended to relieve symptoms of obstructive Benign Prostatic Hyperplasia (BPH).
Detailed description
A multi-center, prospective, single arm safety, performance, and effectiveness trial. The study will be conducted in two stages. Upon the successful completion of stage 1, the study will be expanded and continue to stage 2.
Stage 1 will enroll subjects in the Intent to Treat (ITT) cohort. The purpose of stage 1 is to assess acute safety and performance of the Zenflow System at the time of the procedure, through discharge, 2 weeks and 1 month, in up to 10 subjects enrolled at up to 7 investigational sites, to determine continuation to stage 2.
Upon successful completion of stage 1, the study will be expanded to stage 2 with sites added and continued enrollment in the ITT cohort. All subjects, including those enrolled in the stage 1 evaluation, will continue to be followed at all the designated follow-up time points for the full duration of the study (60 months).
Whether or not the study continues to Stage 2, all enrolled subjects will be followed for the entire duration of the study (60 months), or until exited.
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 |
|---|---|---|
| Treatment Group | Experimental | Device: Zenflow Spring SystemReceives treatment 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 (5 listed)
- All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in this trial:
- ≥ 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), measured within past 90 days and prostatic urethral length between 2.5-4.5 cm.
- Failed or intolerant to medication regimen for the treatment of LUTS.
Key exclusion criteria (25 listed)
- Subjects will be excluded from participating in this trial if they meet any of the following criteria:
- Obstructive intravesical median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer
- Elevated risk of prostate cancer
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 | Treatment Group |
Primary outcome
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.
Need for urinary catheterization
Time frame: 7 days after the procedure
Rate of extended post-operative urinary catheterization
9 secondary outcomes
Incidence of procedure or device related serious adverse events
Time frame: Day of discharge up to 7 days following device placement
Assessment of Pain
Time frame: Baseline, 2 weeks, 1 month and 3 months
Assessment of Adverse Events
Time frame: Up to 2 years
Assessment of Sexual Health: 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: 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
Effectiveness of the Spring Implant in reducing symptoms of Benign Prostatic Hyperplasia (BPH) by patient response to the International Prostate Symptom Score and Quality of Life Questionnaire (IPSS+QoL).
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
Repeat interventions to treat Benign Prostatic Hyperplasia (BPH)
Time frame: Up to 2 years
Increase or change in medications to treat 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.
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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.
Juan J Galan, MD principal investigator
Centro de Urología Avanzada del Noreste (CUAN)
3 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 3 sites in Mexico.
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 5 inclusion and 25 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 3 sites in Mexico. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 2 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 NCT03595735, 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.