Actively Recruiting
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)
Led by Butterfly Medical Ltd. · Updated on 2023-08-08
60
Participants Needed
2
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completed 12 months follow-up under study BM-011-IL, including patients who missed some visits but have data at 12 months follow-up
- Provided signed informed consent for the continuation study
- Willing and able to attend follow-up visits and complete study activities
You will not qualify if you...
- Patients who participated in study BM-011-IL but did not complete the 12 months follow-up visit for any reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
2
Ziv Medical Center
Safed, Israel
Actively Recruiting
Research Team
V
Vardit Segal, Ph.D
CONTACT
I
Idan Geva
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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