- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05330520
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)
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.
Study Overview
Status
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vardit Segal, Ph.D
- Phone Number: +972524579178
- Email: vardit@butterfly-medical.com
Study Contact Backup
- Name: Idan Geva
- Phone Number: +972504043838
- Email: Idan.geva@butterfly-medical.com
Study Locations
-
-
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Petah tikva, Israel
- Recruiting
- Rabin Medical Center
-
Contact:
- Shachar Aharoni, Dr.
- Email: shacharA3@clalit.org.il
-
Contact:
- Inbal Grossman
- Email: inbalgr3@clalit.org.il
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Safed, Israel
- Recruiting
- ZIV Medical Center
-
Contact:
- Ran Katz, Dr.
- Email: ran.k@ziv.health.gov.il
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Contact:
- Yara Safadi
- Email: yara.s@ziv.health.gov.il
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation
Continuation study for Study BM-011-IL
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
60 month post procedure
|
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.
|
60 month post procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of device extraction and re-treatment
Time Frame: 60 month post procedure
|
Rate and Time to device removal and re treatment
|
60 month post procedure
|
Rate of sexual dysfunction
Time Frame: 60 month post procedure
|
Retrograde ejaculation rate in comparison to rate before treatment
|
60 month post procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BM-011-LT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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