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New device aims to ease enlarged prostate for years

NCT ID NCT05330520

Disease control Sponsor: Butterfly Medical Ltd. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 60 men with an enlarged prostate who already used the Butterfly device for a year. Researchers will track safety and symptom relief for up to 5 years. The goal is to see if the device remains effective and safe over the long term.

What this could mean

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

Active substance
Butterfly Medical Prostatic Retraction Device
What this could lead to
If successful, this could confirm a safe, long-term option to relieve BPH symptoms without major surgery.
What could go wrong
This is a small, non-randomized study with no comparison group, so results may not apply to all patients. Device removal or side effects like sexual dysfunction are possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Started

Feb 2021

Expected to finish

Feb 2027

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

50 to 80 years

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: 1. Completed 12 months follow up under study BM-011-IL. A subject that missed one or more visits during BM-011-IL will be included, as long as the subject has collected data at 12 months follow up visit. 2. Provide signed informed consent to the continuation study and be willing and able to perform follow up visits and activities as described in the study protocol. Exclusion Criteria: 1\. Patients which participated in the BM-011-IL study and did not complete 12 months follow up visit under study BM-011-IL due to any reason

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia bladder neck obstruction Retrograde Ejaculation

As listed by the trial registrant

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

Boo - bladder outflow obstruction BPH Enlarged prostate (BPH)

Contacts and locations

Locations

  • Rabin Medical Center

    Petah Tikva, Israel

  • Ziv Medical Center

    Safed, Israel

More trials for these conditions

Other studies related to the condition(s) this trial covers.