Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT03912558 |
Other study ID # |
BM-011 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 23, 2018 |
Est. completion date |
May 2025 |
Study information
Verified date |
March 2023 |
Source |
Butterfly Medical Ltd. |
Contact |
Vardit Segal, Ph.D. |
Phone |
+972524579178 |
Email |
vardit[@]butterfly-medical.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.
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.