Active — Not RecruitingNot Applicable

ProVIDE II Bridging Study

United States40 participantsStarted 2024-03-06

Plain-language summary

The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.

Who can participate

Age range45 Years

SexMALE

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Inclusion criteria

✓. Males \> 45 years of age
✓. IPSS of ≥ 13, IPSS V/S \> 1 at baseline assessment
✓. Prostate volume of ≥ 30 cc and ≤ 80 cc
✓. Prostatic urethral L2 lengths ≥ 3.75 cm by TRUS
✓. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

Exclusion criteria

✕. Void volume \<125 ml; Qmax \> 12 ml/s; PVR \> 250 ml
✕. Obstructive median lobe defined by EITHER \>10mm protrusion on sagittal mid-prostate plane as measured by TRUS OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve''
✕. High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
✕. Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible
✕. Acute urinary retention
✕. Known immunosuppression
✕. History of or suspected prostate or bladder cancer
✕. Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated).

What they're measuring

Serious Adverse Events

Timeframe: (time frame: procedure to 3 months)

Need for urinary catheterization

Timeframe: (time frame: >7 days post procedure to 3-months)

Technical Success

Timeframe: Procedure

Trial details

NCT IDNCT06236802

SponsorProVerum Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-06

View on ClinicalTrials.gov More BPH With Symptomatic Lower Urinary Tract Symptoms trials