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)
Butterfly Medical Ltd.
60 participants
Feb 10, 2021
INTERVENTIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria2
- 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 Criteria1
- \. 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
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05330520