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)

Launched by BUTTERFLY MEDICAL LTD. · Apr 10, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term safety and effectiveness of a device called the Butterfly Medical Prostatic Retraction Device for men with Benign Prostatic Hyperplasia (BPH), which is a condition that causes an enlarged prostate and can lead to bladder issues. The study will follow patients who have already had this device implanted for up to five years to see how well it works and if there are any side effects. Researchers will use tests and questionnaires to check on symptoms related to BPH, how much urine is left in the bladder after using the bathroom, and the overall sexual quality of life for participants.

To join this study, participants must have completed 12 months of follow-up from a previous related study and be willing to continue with follow-up visits. Men aged 18 to 92 who meet these criteria may be eligible. Those who did not finish the 12-month follow-up for any reason will not be able to participate. Overall, participants can expect regular check-ins to monitor their health and gather important information about their experience with the Butterfly device.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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 Criteria:
• • 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