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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250007 / PAS001 |
| Date Original Protocol Accepted |
12/11/2025
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| Date Current Protocol Accepted |
12/11/2025
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| Study Name |
The BREEZE Study - PMCF
|
| Device Name |
Zenflow Spring® Implant and Delivery System
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| Clinical Trial Number(s) |
NCT02786290 NCT03577236 NCT03595735 NCT04309695 NCT04987138
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| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The BREEZE Study - PAS [Post-Approval Study of the Zenflow Spring System - A Minimally Invasive Treatment for LUTS associated with BPH (BREEZE Study CLIN-0130 – Long-term Follow-up)] is a continuation of annual follow-up through 60 months for any subjects who received a Spring Implant in the premarket BREEZE Study. The objective is to evaluate the continued long-term safety and effectiveness of the Zenflow Spring System in relieving lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
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| Study Population |
Subjects enrolled and treated in the premarket BREEEZE Clinical Study (CLIN-0130), i.e., male volunteers greater than or equal to 45 years of age requesting treatment for the symptomatic relief of LUTS secondary to BPH.
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| Sample Size |
A total of 223 subjects underwent a Spring Implant procedure, of which 221 were successfully implanted in the following cohorts:
• Treatment Arm Cohort: N=136
• Crossover Cohort: N=59
• Roll-in Cohort: N=26
These 221 implanted subjects will be followed under this protocol through completion of 60-month follow-up, or through 6 months post implant removal for any subjects who have the implant removed. If no alternative treatments for BPH were performed by 6 months post removal the assessment will be repeated as 12 months.
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| Key Study Endpoints |
Effectiveness assessments:
• Mean change from baseline in International Prostate Symptom Score (IPSS) at 24/36/48/60 months post treatment.
• Mean change from baseline in peak flow rate (Qmax) at 24/36/48/60 months post treatment.
Safety assessments:
• Rate of device or procedure related adverse events (AE) at 24/36/48/60 months post treatment.
• Assessment of AEs outcomes related to a Spring Implant removal procedure.
• Change in sexual health characterized by change in Sexual Health Inventory for Men (SHIM) and Male Sexual Health Questionnaire – Ejaculatory Domain (MSHQ-EjD) at 24/36/48/60 months post treatment.
• Post-procedure incidence of secondary reintervention using an alternate surgical LUTS therapy.
• Post-procedure incidence of secondary reintervention using standard pharmacological agents for LUTS therapy.
Exploratory:
• Mean change in ICIQ-SF Questionnaire at 24/36/48/60 months post treatment.
• Mean change in BII Questionnaire at 24/36/48/60 months post treatment.
• Incidence of reinitiation of BPH medication.
• PSA (if collected).
• Patient Satisfaction.
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| Follow-up Visits and Length of Follow-up |
60 months
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