Benign Prostatic Hyperplasia (BPH)Phase 4NCT07797348
Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.
A Phase 4 study testing Zenflow Arm: Zenflow Spring System implant procedure and Medical Therapy Tamsulosin in people with Benign Prostatic Hyperplasia (BPH) and Obstructive Lower Urinary Tract Symptoms (LUTS), run by Zenflow, Inc..
Trial summary
This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS), Enlarged Prostate
- What is being tested?
- Zenflow Arm: Zenflow Spring System implant procedure and Medical Therapy Tamsulosin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
- In addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:
- Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
- Not actively taking any medication indicated for BPH, defined as current use of:
- Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment
- 5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment
- PDE5 daily use (on demand use is permitted)
- Ability to provide informed consent and comply with study procedures and follow-up schedule
Who cannot join
- Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
- Neurologic conditions affecting bladder function, including but not limited to:
- Multiple sclerosis
- Parkinson's disease
- Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction
About this study
Official title: Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.
Read the detailed description
The purpose of this post-market clinical trial (PMCT) is to compare the Zenflow Spring System with Tamsulosin in men with moderate to severe BPH symptoms who are not currently receiving treatment.
The study will look at how well each treatment works, how long the results last, how quickly patients return to normal activities, how satisfied they are with their treatment, and any side effects. Patients will be followed at 1, 3, 6, and 12 months. The study will also track any implant removals or additional procedures, as well as any changes to or stopping of Tamsulosin.
Patients who qualify for the study will be randomly assigned, with an equal chance, to receive either the Zenflow Spring System or Tamsulosin.
Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria. No crossover will be permitted beyond 30 days after completion of the 12-month follow-up. Patients who elect crossover and have a successful placement of the Spring Implant will be followed for 1 additional month and then will exit the study.
- Conditions
- Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS), Enlarged Prostate
- Being tested
- Zenflow Arm: Zenflow Spring System implant procedure, Medical Therapy Tamsulosin
- Keywords
- obstructive lower urinary tract symptoms (LUTS), Benign Prostatic Hyperplasia (BPH),, enlarged prostate, BPH, LUTS, urinary tract symptoms, Benign Prostatic Hyperplasia, obstructive lower urinary tract symptoms, minimally invasive, relieve prostatic urethral obstruction, early intervention
- 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 Arm: Zenflow Spring System implant procedureDevice
The Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician.
Medical Therapy TamsulosinDrug
Tamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily
| Study group | Role | What they receive |
|---|---|---|
| Zenflow Arm: Zenflow Spring System Treatment | Active comparator | Zenflow Arm: Patients randomized to the Zenflow Spring System arm will undergo the procedure according to manufacturer specifications and standardized procedural protocols. Receives: Device: Zenflow Arm: Zenflow Spring System implant procedure |
| Tamsulosin Treatment | Active comparator | Medical Therapy Arm: Patients randomized to the medical therapy arm will receive Tamsulosin 0.4 mg once daily. Subjects will be encouraged to remain on this medical therapy through at least 3 months of treatment, unless significant adverse health reaction occurs. Receives: Drug: Medical Therapy Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS) Total Score
Mean change in IPSS Total Score from baseline at 3 months. This is a 7-question patient questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better.
Measured: Baseline (Day 1) to 3 months
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
Measured: Baseline through study completion, an average of 1 year (Duration of study)
Secondary outcomes (4)
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months. This is a 7-question questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better
Measured: Baseline at 1, 6, and 12 months
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months. This separate Quality of Life (QoL) question, scored 0-6, is asking how the patient would feel if they had to live with their current urinary condition for the rest of their life. The QoL score is reported separately and is not included in the 0-35 IPSS total
Measured: Baseline 1, 3, 6 and 12 months
Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations
In the Spring Implant arm, the patient will be asked if they remain implanted with the Spring Implant and if since last visit, if patient initiated any concomitant BPH medication use (for > 2 weeks). In the Medical Therapy Arm the patient will be asked since last visit, to confirm if they have been consistently taking Tamsulosin at the required dose.
Measured: Baseline through study completion, an average of 1 year (Study duration)
The observed rates of device related AEs or Tamsulosin-related adverse events
The observed rates of device related AEs or Tamsulosin-related adverse events
Measured: Baseline through study completion, an average of 1 year (Duration of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open-label, parallel-group assignment post-market clinical trial. Option to crossover.
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT07797348
- Sponsor's protocol ID
- CLIN-0298
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH
- ClinicalTrials.gov ID
- NCT07797348
- Acronym / sponsor ID
- CLIN-0298
- Conditions
- Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS), Enlarged Prostate
- Keywords
- obstructive lower urinary tract symptoms (LUTS), Benign Prostatic Hyperplasia (BPH),, enlarged prostate, BPH, LUTS, urinary tract symptoms, Benign Prostatic Hyperplasia, obstructive lower urinary tract symptoms, minimally invasive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zenflow, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 1 Sep 2026 (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 prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring System versus Tamsulosin in men who are not on active therapy with moderate to severe LUTS/BPH. Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria.
Detailed description
The purpose of this post-market clinical trial (PMCT) is to compare the Zenflow Spring System with Tamsulosin in men with moderate to severe BPH symptoms who are not currently receiving treatment.
The study will look at how well each treatment works, how long the results last, how quickly patients return to normal activities, how satisfied they are with their treatment, and any side effects. Patients will be followed at 1, 3, 6, and 12 months. The study will also track any implant removals or additional procedures, as well as any changes to or stopping of Tamsulosin.
Patients who qualify for the study will be randomly assigned, with an equal chance, to receive either the Zenflow Spring System or Tamsulosin.
Patients randomized to the Tamsulosin therapy arm will be allowed to crossover to receive treatment with the Zenflow Spring System after 1) their 3-month follow-up assessments are completed, 2) the patient's symptoms are confirmed to continue to warrant treatment; and 3) the patient continues to meet the study enrollment criteria. No crossover will be permitted beyond 30 days after completion of the 12-month follow-up. Patients who elect crossover and have a successful placement of the Spring Implant will be followed for 1 additional month and then will exit the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label, parallel-group assignment post-market clinical trial. Option to crossover.
| Arm | Type | Receives |
|---|---|---|
| Zenflow Arm: Zenflow Spring System Treatment | Active comparator | Device: Zenflow Arm: Zenflow Spring System implant procedureZenflow Arm: Patients randomized to the Zenflow Spring System arm will undergo the procedure according to manufacturer specifications and standardized procedural protocols. |
| Tamsulosin Treatment | Active comparator | Drug: Medical Therapy TamsulosinMedical Therapy Arm: Patients randomized to the medical therapy arm will receive Tamsulosin 0.4 mg once daily. Subjects will be encouraged to remain on this medical therapy through at least 3 months of treatment, unless significant adverse health reaction occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The Spring® Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25mm and 45mm and prostate sizes between 25cc and 80cc.
- In addition to the above labeling requirements, patients must also meet all the following criteria to be eligible for enrollment in this study:
- Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8)
- Not actively taking any medication indicated for BPH, defined as current use of:
- Ability to provide informed consent and comply with study procedures and follow-up schedule
Key exclusion criteria (5 listed)
- Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin)
- Neurologic conditions affecting bladder function, including but not limited to:
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 Arm: Zenflow Spring System implant procedureThe Zenflow Spring Implant is designed to be a permanent implant but can be repositioned or removed by the physician. | Device | Zenflow Arm: Zenflow Spring System Treatment |
| Medical Therapy TamsulosinTamsulosin is a prescription medicine that relaxes the muscles around the prostate and bladder to help men with an enlarged prostate (BPH) urinate more easily | Drug | Tamsulosin Treatment |
Primary outcome
International Prostate Symptom Score (IPSS) Total Score
Time frame: Baseline (Day 1) to 3 months
Mean change in IPSS Total Score from baseline at 3 months. This is a 7-question patient questionnaire used to measure the severity of lower urinary tract symptoms associated with BPH. Each of the 7 symptom questions is scored from 0 to 5, giving a total possible score of 0-35. Lower scores are better.
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
Time frame: Baseline through study completion, an average of 1 year (Duration of study)
Observed rate of device-related or Tamsulosin-related serious adverse events (SAEs).
4 secondary outcomes
Mean change in International Prostate Symptom Score (IPSS) Total Score from baseline at 1, 6, and 12 months
Time frame: Baseline at 1, 6, and 12 months
Mean change in International Prostate Symptom Score (IPSS) Quality of Life (QoL) from baseline 1, 3, 6 and 12 months
Time frame: Baseline 1, 3, 6 and 12 months
Adherence to assigned treatment (Spring Implant arm or Medical Therapy Arm) and reasons for any discontinuations
Time frame: Baseline through study completion, an average of 1 year (Study duration)
The observed rates of device related AEs or Tamsulosin-related adverse events
Time frame: Baseline through study completion, an average of 1 year (Duration of study)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zenflow Arm: Zenflow Spring System implant procedure and Medical Therapy Tamsulosin in people with Benign Prostatic Hyperplasia (BPH) and Obstructive Lower Urinary Tract Symptoms (LUTS), run by Zenflow, Inc..
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
International Prostate Symptom Score (IPSS) Total Score (time frame: Baseline (Day 1) to 3 months). 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?
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 1 Sep 2026.