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Can a tiny spring implant replace daily pills for enlarged prostate?

NCT ID NCT07797348

Disease control Sponsor: Zenflow, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether a small spring implant placed in the prostate can ease urinary symptoms as well as or better than the daily medication tamsulosin. Men with moderate to severe symptoms from an enlarged prostate, known as BPH, will be randomly assigned to receive either the implant or the drug. The study tracks symptom scores and safety over a year, and men on the medication may later choose to get the implant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zenflow Spring System implant procedure and tamsulosin
What this could lead to
If it works, the Zenflow Spring implant could offer men with enlarged prostate a one-time, minimally invasive alternative to daily medication, potentially improving symptoms and quality of life.
What could go wrong
This is a post-market study, so the device is already available, but it may not prove better than tamsulosin, and the implant carries risks like any procedure, including possible need for removal or repositioning.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: 1. Moderate to severe LUTS, defined as an International Prostate Symptom Score (IPSS ≥ 8) 2. Not actively taking any medication indicated for BPH, defined as current use of: 1. Alpha-adrenergic antagonists (Alpha Blockers) within 2 weeks of baseline IPSS assessment 2. 5-alpha reductase inhibitors (5ARI) within 6 months of baseline IPSS assessment 3. PDE5 daily use (on demand use is permitted) 3. Ability to provide informed consent and comply with study procedures and follow-up schedule Exclusion Criteria: 1. Known, previous adverse reaction to use of alpha-adrenergic antagonists (e.g., Tamsulosin) 2. Neurologic conditions affecting bladder function, including but not limited to: 1. Multiple sclerosis 2. Parkinson's disease 3. Neurogenic bladder or other conditions causing non-obstructive voiding dysfunction

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia (BPH) Enlarged prostate Obstructive lower urinary tract symptoms (LUTS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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