RecruitingNot ApplicableNCT05330520

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)


Sponsor

Butterfly Medical Ltd.

Enrollment

60 participants

Start Date

Feb 10, 2021

Study Type

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

Sex: MALEMin Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This is a continuation study for men with benign prostatic hyperplasia (BPH — an enlarged prostate) who previously completed 12 months of follow-up after receiving the Butterfly Medical device, which holds the prostate lobes apart to improve urinary flow without removing tissue. You may be eligible if: - You are a male patient between 50 and 80 years old - You previously completed the 12-month follow-up visit in the original BM-011-IL study You may NOT be eligible if: - You participated in the original study but did not complete the 12-month follow-up visit for any reason Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREButterfly 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

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NCT05330520


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