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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250011 / PAS002 |
| Date Original Protocol Accepted |
12/09/2025
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| Date Current Protocol Accepted |
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| Study Name |
F/u of the ProVIDE II Bridging Study
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| Device Name |
ProVee System for BPH
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| Clinical Trial Number(s) |
NCT05186740 NCT06236802
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study was initiated prior to device approval and is a prospective, multi-center, non-randomized bridging study. It was conducted at 8 sites and enrolled 40 subjects. Forty (40) subjects were implanted in the study. The 3-month outcomes from the study were used to support PMA approval. The 60-months follow-up safety data, and effectiveness data from this study must be submitted to assess the continued safety and effectiveness of the ProVee System for BPH.
No greater than 20% of the patients enrolled in the study will be lost to follow up through 60-months.
Data must be summarized descriptively, without statistical testing. Patient and physician labeling must be updated annually via a PMA supplement to include the effectiveness and safety outcomes listed above after the patients enrolled in this study complete each annual year of follow up.
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| Study Population |
Male subject greater than or equal to 45 years old who has symptomatic BPH
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| Sample Size |
A total of 40 subjects were enrolled in the ProVIDE II Bridging Study.
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| Key Study Endpoints |
Effectiveness
• Symptom improvement 1 (timeframe: procedure through 60 months)
Percent of subjects who experienced at least a 30% improvement in IPSS from baseline from their baseline pre-treatment score annually through 60 months post treatment.
• Symptom improvement 2 (timeframe: procedure through 60-months)
Percent change in IPSS compared to baseline at all timepoints post treatment.
• QoL Questionnaire (timeframe: procedure through 60-months)
Mean improvement from baseline in QoL questionnaire annually through 60-months.
• Uroflow Metrics 1 (timeframe: 1-month through 60-months)
Mean improvement from baseline uroflowmetry measures of peak flow rate (Qmax) as measured at all timepoints.
• Uroflow Metrics 2 (timeframe: 1-month through 60-months)
Mean improvement from baseline in PVR as measured at all timepoints post treatment.
• Re-intervention – device (timeframe: procedure annually through 60-months)
post-procedure incidence of secondary reintervention using an alternative surgical LUTS therapy annually through 60 months.
• Re-intervention – drug (timeframe: procedure annually through 60-months).
Post-procedure incidence of secondary reintervention using standard pharmacological agents for LUTS therapy through 60 months.
• Post procedure device removal rate (timeframe: 12-months through 60-months)
Rate of post procedure incidence of device removal and summary of the reasons for removal.
Safety
• Adverse Events (Procedure through 5 years)
Rate of device or procedure related adverse events at all time points.
• Sexual Health Questionnaire (timeframe 3 months through 60-months)
Change in sexual health characterized by change in International Index of Erectile Function, specifically the Erectile Function domain (IIEF-5) and Male Sexual Health Questionnaire – Ejaculatory Domain (MSHQ-EjD) at 3 months through 60 months.
• Adverse Event Classification (timeframe: procedure through 60-months)
Proportion of subjects with adverse events classified as Clavien-Dindo Grade IIIb or higher or any event resulting in persistent disability evidenced through 60-month follow-up visit.
• Device removal related adverse events (timeframe: procedure through 60-months)
Assessment of retrieval procedure related adverse events related to implant removal.
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| Follow-up Visits and Length of Follow-up |
Follow-up annually through 5 years
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