BPHNCT03912558
Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in BPH Patients.
A study testing Butterfly device implantation in people with BPH and BOO - Bladder Outflow Obstruction, run by Butterfly Medical Ltd. at 4 sites in Israel.
Trial summary
This study evaluates the 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 1 year after implantation. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- BPH, BOO - Bladder Outflow Obstruction
- What is being tested?
- Butterfly device implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesIsrael
- Study dates
- 29 Oct 2018to 1 Apr 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 or older
- Verified BPH with prostate size of at least 30 grams or of 25 mm.
- Signed Informed Consent
- Failure, intolerance or patient non-compliance of medical treatment
- Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec)
- Patient's voided volume of at least 125 ml in uroflow test
- Patients not eligible for surgery or refusing surgery
Who cannot join
- Known sensitivity to Nickel
- Active Prostatitis
- Urethral strictures
- Prior surgery of prostate (simple or radical)
- Currently active bladder tumor
- Suspected neurogenic urinary bladder
Show all 16Show fewer
- Suspected a-contractile bladder
- Enlarged median lobe of prostate.
- Bladder Neck stricture or contracture
- Urethral pathology: diverticula, strictures, tumors, fistula
- Clinically Significant urinary tract infection
- Uncontrolled bleeding disorders
- Uncontrolled diabetes mellitus
- Severe medical diseases precluding a minimally invasive procedure
- Present active urinary stone disease
- Patients who are under anticoagulants therapy
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Shamir Medical Center
Be’er Ya‘aqov
Bnei Zion
Haifa
Rabin Medical Center
Petah Tikva
Ziv Medical Center
Safed
About this study
Official title: Prospective, Open-Label, Non-Comparative, Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
This study evaluates the 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 1 year after implantation.
Evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests and International Prostate Symptom Score (IPSS) questionnaires. The study also assess sexual quality of life after implantation of the Butterfly device.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland that may restrict the flow of urine from the bladder. BPH is a cellular proliferative process of the prostate, also referred as enlarged prostate.
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.
Approximately half of those diagnosed with histopathologic BPH demonstrate moderate-to-severe BPH related symptoms (also known as Lower Urinary Tract Symptoms = LUTS), including 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.
In current clinical practice, most patients are initially treated with medical therapy, usually with alpha-blockers. A minimally invasive treatment alternative is the use of urethral stents to preserve flow of urine from the bladder. Such stents are also associated with several problems such as encrustation, stone formation, pain, infection, migration and others. Another alternative is the gold standard treatment for managing benign prostatic hyperplasia; the trans urethral resection of prostate (TURP) surgery. Complications associate with TURP procedure include retrograde ejaculation, urinary incontinence, erectile dysfunction, urethral stricture, and others.
The Butterfly Medical Prostatic Retraction Device is a definitive device intended for transurethral insertion into the male prostatic urethra diagnosed with Bladder Outlet Obstruction (BOO), caused by an enlarged prostate gland. It is a single use device intended to remain permanently in the prostate urethra, to open the occluded urethral passage. The Butterfly device has a specific shape adjusted to fit the prostatic urethral lumen, and is designed to reside only in the prostate urethra without migration to the urinary bladder or the bulbar urethra. Unlike other forms of treatment, the Butterfly device does not inflict any damage to the bladder neck, preventing irritation or retrograde ejaculation.
- Conditions
- BPH, BOO - Bladder Outflow Obstruction
- Being tested
- Butterfly device implantation
- Keywords
- BPH, BOO, Enlarged prostate, LUTS, Urinary obstruction, Retrograde ejaculation
- Medical subject headings
- Retrograde Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly device implantationProcedure or surgery
The Butterfly device will be positioned and deployed with cystoscopy guidance
| Study group | Role | What they receive |
|---|---|---|
| Butterfly device implantation | Experimental | Butterfly device implantation will be performed following initial cystoscopy to evaluate prostate condition and rule out other pathologies.
Following implant size selection, the Butterfly implant will be deployed and positioned through the cystoscope over-sheath. After deployment the cystoscope (with its optics) will be re-introduced into the urethra to examine the Butterfly device position. Receives: Procedure: Butterfly device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported device related adverse events
Assess the rate, nature and severity of device-related adverse events reported
Measured: 12 months post procedure
Cystoscopic assessment - inflammation
Cystoscopic assessment to evaluate lack of local inflammation
Measured: 12 months post procedure
Cystoscopic assessment - incrustations
Cystoscopic assessment to evaluate no incrustations
Measured: 12 months post procedure
Cystoscopic assessment - implant coverage
Cystoscopic assessment to evaluate coverage by mucosa
Measured: 12 months post procedure
Device migration
Rate of migration of the Butterfly device
Measured: 12 months post procedure
Secondary outcomes (4)
Symptoms reduction - IPSS
Improvement in IPSS at 12 months compared to baseline
Measured: Baseline to 12 months post procedure
Symptoms reduction - Qmax
Improvement in Qmax (by uroflowmetry) at 12 months compared to baseline
Measured: Baseline to 12 months post procedure
Sexual quality of life evaluation - erectile dysfunction
Rate of de-novo sustained erectile dysfunction
Measured: 12 month post procedure
Sexual quality of life evaluation - retrograde ejaculation
Rate of de-novo sustained retrograde ejaculation
Measured: 12 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 posted11 Apr 2019
- Study start29 Oct 2018
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butterfly Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912558
- Sponsor's protocol ID
- BM-011
- Status last verified
- Aug 2024
- First submitted
- 7 Apr 2019
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-Label, Non-Comparative, Pilot Study to Assess the Safety and Efficacy of Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
- ClinicalTrials.gov ID
- NCT03912558
- Acronym / sponsor ID
- BM-011
- Conditions
- BPH, BOO - Bladder Outflow Obstruction
- Keywords
- BPH, BOO, Enlarged prostate, LUTS, Urinary obstruction, Retrograde ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Butterfly Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 11 Apr 2019 (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 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 1 year after implantation.
Evaluations include recording of safety events and BPH related symptoms by Uroflowmetry tests and International Prostate Symptom Score (IPSS) questionnaires. The study also assess sexual quality of life after implantation of the Butterfly device.
Detailed description
Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland that may restrict the flow of urine from the bladder. BPH is a cellular proliferative process of the prostate, also referred as enlarged prostate.
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.
Approximately half of those diagnosed with histopathologic BPH demonstrate moderate-to-severe BPH related symptoms (also known as Lower Urinary Tract Symptoms = LUTS), including 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.
In current clinical practice, most patients are initially treated with medical therapy, usually with alpha-blockers. A minimally invasive treatment alternative is the use of urethral stents to preserve flow of urine from the bladder. Such stents are also associated with several problems such as encrustation, stone formation, pain, infection, migration and others. Another alternative is the gold standard treatment for managing benign prostatic hyperplasia; the trans urethral resection of prostate (TURP) surgery. Complications associate with TURP procedure include retrograde ejaculation, urinary incontinence, erectile dysfunction, urethral stricture, and others.
The Butterfly Medical Prostatic Retraction Device is a definitive device intended for transurethral insertion into the male prostatic urethra diagnosed with Bladder Outlet Obstruction (BOO), caused by an enlarged prostate gland. It is a single use device intended to remain permanently in the prostate urethra, to open the occluded urethral passage. The Butterfly device has a specific shape adjusted to fit the prostatic urethral lumen, and is designed to reside only in the prostate urethra without migration to the urinary bladder or the bulbar urethra. Unlike other forms of treatment, the Butterfly device does not inflict any damage to the bladder neck, preventing irritation or retrograde ejaculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Butterfly device implantation | Experimental | Procedure: Butterfly device implantationButterfly device implantation will be performed following initial cystoscopy to evaluate prostate condition and rule out other pathologies. Following implant size selection, the Butterfly implant will be deployed and positioned through the cystoscope over-sheath. After deployment the cystoscope (with its optics) will be re-introduced into the urethra to examine the Butterfly device position. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 50 or older
- Verified BPH with prostate size of at least 30 grams or of 25 mm.
- Signed Informed Consent
- Failure, intolerance or patient non-compliance of medical treatment
- Patients suffering from LUTS symptoms of BPH (IPSS >12, Qmax=<13 ml/sec)
Key exclusion criteria (16 listed)
- Known sensitivity to Nickel
- Active Prostatitis
- Urethral strictures
- Prior surgery of prostate (simple or radical)
- Currently active bladder tumor
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 device implantationThe Butterfly device will be positioned and deployed with cystoscopy guidance | Procedure or surgery | Butterfly device implantation |
Primary outcome
Reported device related adverse events
Time frame: 12 months post procedure
Assess the rate, nature and severity of device-related adverse events reported
Cystoscopic assessment - inflammation
Time frame: 12 months post procedure
Cystoscopic assessment to evaluate lack of local inflammation
Cystoscopic assessment - incrustations
Time frame: 12 months post procedure
Cystoscopic assessment to evaluate no incrustations
Cystoscopic assessment - implant coverage
Time frame: 12 months post procedure
Cystoscopic assessment to evaluate coverage by mucosa
Device migration
Time frame: 12 months post procedure
Rate of migration of the Butterfly device
4 secondary outcomes
Symptoms reduction - IPSS
Time frame: Baseline to 12 months post procedure
Symptoms reduction - Qmax
Time frame: Baseline to 12 months post procedure
Sexual quality of life evaluation - erectile dysfunction
Time frame: 12 month post procedure
Sexual quality of life evaluation - retrograde ejaculation
Time frame: 12 month post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for BPH
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly device implantation in people with BPH and BOO - Bladder Outflow Obstruction, run by Butterfly Medical Ltd. at 4 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reported device related adverse events (time frame: 12 months post procedure). The study lists 5 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 6 Aug 2024.