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)
NCT ID: NCT05330520
Last Updated: 2023-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-02-10
2027-02-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation
Continuation study for Study BM-011-IL
Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement
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.
Interventions
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Butterfly Medical Prostatic Retraction Device ("the Butterfly device") removal/replacement
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.
Eligibility Criteria
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Inclusion Criteria
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
50 Years
80 Years
MALE
No
Sponsors
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Butterfly Medical Ltd.
INDUSTRY
Responsible Party
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Locations
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Rabin Medical Center
Petah Tikva, , Israel
Ziv Medical Center
Safed, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BM-011-LT
Identifier Type: -
Identifier Source: org_study_id
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