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Treatment for Benign Prostatic Obstruction: Transperineal Laser Ablation

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Record History

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  1. Notable Primary endpoint(s) modified
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: 2 to 11
    • Study title shortened, about 18 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TRANSPERINEAL LASER ABLATION (TPLA) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.
Trial Details
NCT Number NCT07289243
Lead Sponsor Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Conditions
(from sponsor)
RANDOMIZED
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov