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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)
Sponsor: Butterfly Medical Ltd.
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.
Official title: 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)
Key Details
Gender
MALE
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-02-10
Completion Date
2027-02-01
Last Updated
2023-08-08
Healthy Volunteers
No
Interventions
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.
Locations (2)
Rabin Medical Center
Petah Tikva, Israel
Ziv Medical Center
Safed, Israel