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)
1 other identifier
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2021
CompletedFirst Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
August 8, 2023
August 1, 2023
6 years
March 28, 2022
August 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Serious adverse events (SAEs) and adverse events (AEs) related to the Butterfly Device.
Serious adverse events (SAEs) and adverse events (AEs) related to treatment with the Butterfly Device.
60 month post procedure
Change in IPSS change in post implantation patients.
Evaluate the change in IPSS during the FU at each timepoints in comparison to baseline before treatment.
60 month post procedure
Secondary Outcomes (2)
Incidence of device extraction and re-treatment
60 month post procedure
Rate of sexual dysfunction
60 month post procedure
Study Arms (1)
Patients Who Completed 12 Months of Follow-Up Post Butterfly Implantation
EXPERIMENTALContinuation study for Study BM-011-IL
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rabin Medical Center
Petah Tikva, Israel
Ziv Medical Center
Safed, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2022
First Posted
April 15, 2022
Study Start
February 10, 2021
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
August 8, 2023
Record last verified: 2023-08