Long-term evaluation of a device for enlarged prostate treatment
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)
This study is testing a new device for treating an enlarged prostate to see how safe and effective it is for men with BPH over a period of up to five years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Male |
| Sponsor | Butterfly Medical Ltd. Industry-sponsored |
| Locations | 2 sites (Petah Tikva and 1 other locations) |
| Trial ID | NCT05330520 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety and efficacy of the Butterfly Medical Prostatic Retraction Device in patients with Benign Prostatic Hyperplasia (BPH) who have completed 12 months of follow-up after implantation. Participants will be monitored for up to 5 years, with assessments including safety events, urinary flow tests, residual urine measurements, and International Prostate Symptom Score (IPSS) questionnaires. Additionally, the study will assess the impact of the device on sexual quality of life.
Who should consider this trial
Good fit: Ideal candidates are men who have completed 12 months of follow-up in the previous study BM-011-IL and are willing to continue participating.
Not a fit: Patients who did not complete the 12 months follow-up in the previous study will not benefit from this continuation study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for men suffering from BPH and its associated symptoms.
How similar studies have performed: While this approach is based on previous studies, the long-term evaluation of this specific device is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Petah Tikva and 1 other locations
- Rabin Medical Center — Petah Tikva, Israel (Recruiting)
- Ziv Medical Center — Safed, Israel (Recruiting)
Study contacts
- Study coordinator: Vardit Segal, Ph.D
- Email: vardit@butterfly-medical.com
- Phone: +972524579178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.