BPHNCT05330520
Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients Who Completed 12 Months of Follow-Up Post Implantation (Continuation Study for Study BM-011-IL)
A study testing Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement in people with BPH and BOO - Bladder Outflow Obstruction, run by Butterfly Medical Ltd. at 2 sites in Israel.
Trial summary
This study evaluates the long term safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 5 year after implantation. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- BPH, BOO - Bladder Outflow Obstruction, Enlarged Prostate (BPH)
- What is being tested?
- Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesIsrael
- Study dates
- 10 Feb 2021to 1 Feb 2027
- Phase
- Interventional
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prospective, Open-Label, Non-Comparative, Study to Assess the Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients Who Completed 12 Months of Follow-Up Post Implantation (Continuation Study for Study BM-011-IL)
This study evaluates the long term safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 5 year after implantation.
The evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests, residual urine and International Prostate Symptom Score (IPSS) questionnaires. The study also assesses the sexual quality of life after implantation of the Butterfly device.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate gland that may restrict the flow of urine from the bladder.
BPH is a proliferative process of the cellular elements of the prostate, also referred as enlarged prostate. Cellular accumulation and gland enlargement may be due to epithelial and stromal proliferation, impaired pre-programmed cell death (apoptosis), or both. More recently, the voiding dysfunction that ensues from prostate gland enlargement and bladder outlet obstruction (BOO) has been generically termed lower urinary tract symptoms (LUTS). These entities overlap; not all men with BPH have LUTS, and, likewise, not all men with LUTS have BPH. The same can be said for BOO.
An estimated 50% of men demonstrate histopathologic BPH by age 60 years. This number increases to 90% by age 85 years; thus, increasing gland size is considered a normal part of the aging process (2-5).
Approximately half of those diagnosed with histopathologic BPH demonstrate moderate-to-severe LUTS. Clinical manifestations of LUTS include urinary frequency, urgency, nocturia (getting up at night during sleep to urinate), decreased or intermittent force of stream, or a sensation of incomplete emptying. Complications occur less commonly but may include acute urinary retention, impaired bladder emptying, or the need for surgery.
The Butterfly Medical Prostatic Retraction Device is a retraction device, specially designed to be delivered into the prostatic urethra and indicated to dilate the prostatic urethra in BPH patients. This device was specially designed to reduce most of the known complications of used urethral stents.
The current clinical study is aimed to investigate the long term technical performance and clinical usage of Butterfly Medical Prostatic Retraction Device, through a 4 year follow up period, as a continuation of study BM-011-IL which assessed the above for a duration of 12 month post implantation.
- Being tested
- Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement
- Keywords
- LUTS, Urinary obstruction, Retrograde ejaculation
- Medical subject headings
- Prostatic Hyperplasia, Retrograde Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacementProcedure or surgery
when necessary, the device may be removed or replaced easily through the urethra due to its minimal surface and easy release from the mucosa covering it.
| Study group | Role | What they receive |
|---|---|---|
| Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation | Experimental | Continuation study for Study BM-011-IL Receives: Procedure: Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious adverse events (SAEs) and adverse events (AEs) related to the Butterfly Device.
Serious adverse events (SAEs) and adverse events (AEs) related to treatment with the Butterfly Device.
Measured: 60 month post procedure
Change in IPSS change in post implantation patients.
Evaluate the change in IPSS during the FU at each timepoints in comparison to baseline before treatment.
Measured: 60 month post procedure
Secondary outcomes (2)
Incidence of device extraction and re-treatment
Rate and Time to device removal and re treatment
Measured: 60 month post procedure
Rate of sexual dysfunction
Retrograde ejaculation rate in comparison to rate before treatment
Measured: 60 month post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start10 Feb 2021
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butterfly Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330520
- Sponsor's protocol ID
- BM-011-LT
- Status last verified
- May 2026
- First submitted
- 28 Mar 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Non-Comparative, Study to Assess the Long Term Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients Who Completed 12 Months of Follow-Up Post Implantation (Continuation Study for Study BM-011-IL)
- ClinicalTrials.gov ID
- NCT05330520
- Acronym / sponsor ID
- BM-011-LT
- Keywords
- LUTS, Urinary obstruction, Retrograde ejaculation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Butterfly Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 Apr 2022 (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 study evaluates the long term safety and efficacy of use of the Butterfly Medical's prostatic retraction device in Benign Prostatic Hyperplasia (BPH) Patients. The study follows patients implanted with the Butterfly device for up to 5 year after implantation.
The evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests, residual urine and International Prostate Symptom Score (IPSS) questionnaires. The study also assesses the sexual quality of life after implantation of the Butterfly device.
Detailed description
Benign prostatic hyperplasia (BPH) is a noncancerous enlargement of the prostate gland that may restrict the flow of urine from the bladder.
BPH is a proliferative process of the cellular elements of the prostate, also referred as enlarged prostate. Cellular accumulation and gland enlargement may be due to epithelial and stromal proliferation, impaired pre-programmed cell death (apoptosis), or both. More recently, the voiding dysfunction that ensues from prostate gland enlargement and bladder outlet obstruction (BOO) has been generically termed lower urinary tract symptoms (LUTS). These entities overlap; not all men with BPH have LUTS, and, likewise, not all men with LUTS have BPH. The same can be said for BOO.
An estimated 50% of men demonstrate histopathologic BPH by age 60 years. This number increases to 90% by age 85 years; thus, increasing gland size is considered a normal part of the aging process (2-5).
Approximately half of those diagnosed with histopathologic BPH demonstrate moderate-to-severe LUTS. Clinical manifestations of LUTS include urinary frequency, urgency, nocturia (getting up at night during sleep to urinate), decreased or intermittent force of stream, or a sensation of incomplete emptying. Complications occur less commonly but may include acute urinary retention, impaired bladder emptying, or the need for surgery.
The Butterfly Medical Prostatic Retraction Device is a retraction device, specially designed to be delivered into the prostatic urethra and indicated to dilate the prostatic urethra in BPH patients. This device was specially designed to reduce most of the known complications of used urethral stents.
The current clinical study is aimed to investigate the long term technical performance and clinical usage of Butterfly Medical Prostatic Retraction Device, through a 4 year follow up period, as a continuation of study BM-011-IL which assessed the above for a duration of 12 month post implantation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation | Experimental | Procedure: Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacementContinuation study for Study BM-011-IL |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacementwhen necessary, the device may be removed or replaced easily through the urethra due to its minimal surface and easy release from the mucosa covering it. | Procedure or surgery | Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation |
Primary outcome
Incidence of Serious adverse events (SAEs) and adverse events (AEs) related to the Butterfly Device.
Time frame: 60 month post procedure
Serious adverse events (SAEs) and adverse events (AEs) related to treatment with the Butterfly Device.
Change in IPSS change in post implantation patients.
Time frame: 60 month post procedure
Evaluate the change in IPSS during the FU at each timepoints in comparison to baseline before treatment.
2 secondary outcomes
Incidence of device extraction and re-treatment
Time frame: 60 month post procedure
Rate of sexual dysfunction
Time frame: 60 month post procedure
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 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement in people with BPH and BOO - Bladder Outflow Obstruction, run by Butterfly Medical Ltd. at 2 sites in Israel.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. 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 Israel. 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?
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?
Incidence of Serious adverse events (SAEs) and adverse events (AEs) related to the Butterfly Device. (time frame: 60 month post procedure). 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 Jun 2026.