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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P250011 / PAS001 |
| Date Original Protocol Accepted |
12/09/2025
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| Date Current Protocol Accepted |
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| Study Name |
F/u for the ProVIDE Pivotal 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 |
Device Subjects Serve as Own 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, double-blind, 2:1 randomized, sham controlled clinical study. It was conducted at 17 sites and enrolled 221 subjects. One hundred and fifty (150) subjects were implanted in the study in the treatment arm (71 subjects underwent control). The 12-month outcomes from the study were used to support PMA approval. The 60-months follow-up data from this study must be submitted to assess the continued safety and effectiveness of the ProVee Expander System.
No greater than 20% the patients enrolled in the study (i.e., patients enrolled in the treatment arm and patients crossed over from the sham to treatment arm) 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 221 subjects were enrolled in the ProVIDE study. 150 were randomized to the ProVee Treatment arm and 71 were randomized to the Sham Control Arm.
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| Key Study Endpoints |
Effectiveness
• Long term symptom improvement 1 (timeframe: procedure through 60-months)
Percent of subjects who experience at least a 30% improvement in IPSS from their baseline pre-treatment score at 1, 3, 6-month and annually post treatment.
• Long term symptom improvement 2 (timeframe: procedure through 60-months)
Percent change in IPSS in the treatment arm compared to baseline at all timepoints post treatment.
• QoL Questionnaire (timeframe: procedure through 60-months)
Mean improvement from baseline in QoL questionnaire at 3, 6, 12-month follow-up visits, and 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 through 60-months)
Post-procedure incidence of secondary reintervention using alternate surgical LUTS therapy annually through 60 months.
• Re-intervention – drug (timeframe: procedure 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 60-month)
Rate of device or procedure related adverse events at all time points.
• Sexual Health Questionnaire (timeframe: 3 months post procedure through 60-months post procedure)
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, 6, 12 month and annually post treatment 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-months.
• 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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