BPH (Benign Prostatic Hyperplasia)NCT05341661
Butterfly Pivotal Study
A study testing Butterfly Prostatic Retraction Device in people with BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), run by Butterfly Medical Ltd. at 3 sites in United States.
Trial summary
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Read more about this study
- Who is it for?
- Ages 50 to 120 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)
- What is being tested?
- Butterfly Prostatic Retraction Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 245 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Apr 2022to 31 Dec 2029
- 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 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient age 50 and up
- Willing and able to sign informed consent
- Willing and able to comply with all study assessments
- Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).
- Prostate volume 30-90 ml
- Symptomatic BPH: IPSS ≥ 13; ≥ 1 in the IPSS voiding to sub-score ratio (IPSS-V/S)
Who cannot join
- Known sensitivity to Nickel.
- Current urinary retention
- Urinary stress incontinence (sphincter)
- Biopsy of the prostate within the last 6 weeks
- Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer. Patients with a PSA level above 2.5 ng/mL, in which free PSA is < 25% of total PSA in whom cancer was not ruled out by biopsy.
- Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
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- Obstructing intraprostatic median lobe (e.g., more than 10mm intravesical prostatic protrusion).
- Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent.
- Anatomical anomalies that will not accommodate the retractor, as determined by cystoscopy (e.g., prostatic urethral length to height geometry, absence of bladder neck)
- Prior surgery or minimal invasive procedure of prostate (brachytherapy and PAE patients are not excluded if they show significant obstruction in urodynamic test and cystoscopy shows no significant fibrosis).
- Currently active bladder tumor or intravesical instillation.
- History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic or atonic bladder, Parkinson's disease, multiple sclerosis, etc.).
- Suspected Neurogenic or atonic urinary bladder.
- Suspected Polyuria/Nocturnal Polyuria.
- Suspected overactive bladder
- High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator
- Urethral pathology: diverticula, strictures, tumors, fistula.
- Acute clinically Significant urinary tract infection.
- Uncontrolled bleeding disorders.
- Active stone disease (urinary stone increase in size during the last 3 months/ stone passage during the last 3 months/ presence of cystolithiasis)
- Taking 5 alpha reductase inhibitors within 6 months of baseline evaluation
- Taking one of the following within 2 weeks of baseline evaluation:
- alpha-blockers,
- imipramine,
- anticholinergics,
- Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,
- Beta-3 adrenergic receptor agonist (Mirabegron),
- Taking androgens, unless eugonadal state for at least 2 months or greater as documented by the Investigator
- Taking Gonadotrophin releasing hormone analogues within 12 months of baseline evaluation
- Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
- phenylephrine, or, pseudoephedrine,
- One of the following baseline test results, taken from a single uroflowmetry reading:
- Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
- Peak urinary flow rate (Qmax) of ≤ 5 ml/second and > 15 mL/second,
- Post- void residual volume (PVR) > 250 mL
- Inmates, patient with physical, psychological (such as developmentally delayed adults), or medical impairment that might prevent study completion or would confound study results (including patient questionnaires) in the judgment of the Investigator
- Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Houston Methodist
Houston, Texas, 77030
Manhattan Medical Research
New York, New York, 10016
Northwell Health
Syosset, New York, 11791
About this study
Official title: A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure
- Being tested
- Butterfly Prostatic Retraction Device
- Keywords
- BPH, LUTS
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly Prostatic Retraction DeviceDevice
Implantation of the Butterfly device
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | The active arm patients undergo the Butterfly device procedure. Receives: Device: Butterfly Prostatic Retraction Device |
| Sham Comparator | Sham comparator | The sham control arm patients undergo a rigid cystoscopy procedure. Receives: Device: Butterfly Prostatic Retraction Device |
| Cross over | Other | Sham arm patient is allowed to crossover and undergo the Butterfly procedure Receives: Device: Butterfly Prostatic Retraction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.
Analysis will compare the active and control study arms IPSS
Measured: 3 month
Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months
Analysis will assess the IPSS percent change for the active arm compared to a baseline score
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start7 Apr 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butterfly Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Paz, MD, Study director, Medical director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341661
- Sponsor's protocol ID
- CL-BM14-001
- Status last verified
- May 2026
- First submitted
- 20 Dec 2021
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Blinded Study to Assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in BPH Patients
- ClinicalTrials.gov ID
- NCT05341661
- Acronym / sponsor ID
- CL-BM14-001
- Keywords
- BPH, LUTS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Butterfly Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 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.
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score change from time zero to 12 months. Patients in the active arm undergo Butterfly device treatment. Patients in the control arm undergo a sham rigid cystoscopy procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Butterfly Prostatic Retraction DeviceThe active arm patients undergo the Butterfly device procedure. |
| Sham Comparator | Sham comparator | Device: Butterfly Prostatic Retraction DeviceThe sham control arm patients undergo a rigid cystoscopy procedure. |
| Cross over | Other | Device: Butterfly Prostatic Retraction DeviceSham arm patient is allowed to crossover and undergo the Butterfly procedure |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male patient age 50 and up
- Willing and able to sign informed consent
- Willing and able to comply with all study assessments
- Prostate length of 25mm-45mm (from apex of the prostate to the beginning of the bladder neck).
- Prostate volume 30-90 ml
Key exclusion criteria (37 listed)
- Known sensitivity to Nickel.
- Current urinary retention
- Urinary stress incontinence (sphincter)
- Biopsy of the prostate within the last 6 weeks
- Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer. Patients with a PSA level above 2.5 ng/mL, in which free PSA is < 25% of total PSA in whom cancer was not ruled out by biopsy.
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 Prostatic Retraction DeviceImplantation of the Butterfly device | Device | Active, Cross over, Sham Comparator |
Primary outcome
Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score.
Time frame: 3 month
Analysis will compare the active and control study arms IPSS
Change in active arm International Prostate Symptom Score (IPSS) from baseline to 12 months
Time frame: 12 month
Analysis will assess the IPSS percent change for the active arm compared to a baseline score
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 29 May 2026.
- Individual participant dataSharing planned: No
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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.
Adrian Paz, MD study director
Medical director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly Prostatic Retraction Device in people with BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms (LUTS), run by Butterfly Medical Ltd. at 3 sites in United States.
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 6 inclusion and 37 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Change from baseline to month 3 in International Prostate Symptom Score (IPSS) Score. (time frame: 3 month). 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 29 May 2026.