Status:
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)
Lead Sponsor:
Butterfly Medical Ltd.
Conditions:
BPH
BOO - Bladder Outflow Obstruction
Eligibility:
MALE
50-80 years
Phase:
NA
Brief Summary
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 implante...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05330520
Start Date
February 10 2021
End Date
February 1 2027
Last Update
August 8 2023
Active Locations (2)
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1
Rabin Medical Center
Petah Tikva, Israel
2
Ziv Medical Center
Safed, Israel