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Optilume™ BPH Catheter System in Men With Symptomatic BPH

Study acronym: PINNACLE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Collaborators shortened, about 2 wordsv17
  2. Results first posted: Apr 9, 2025v16
  3. Enrollment target: 148 to 162v15
  4. 2 versions Re-verified since Nov 21, 2024, no change to tracked fieldsv13-v14
  5. Primary endpoints revised (2)
    • Study description expanded, about 79 words
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Enrollment target: estimated 500 to confirmed 148
    • Study title shortened, about 11 words
    v11
  2. Primary completion date changed from estimate of Sep 2022 to Aug 23, 2022
    • Study completion date: Oct 2026 to May 2027
    v10
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 23 to 21
    v9
  4. Site details revised at 3 of 23 sitesv8
  5. Site details revised at 13 of 23 sites
    • Eligibility criteria expanded, about 4 words
    v7
  6. Primary completion date: Jun 2021 to Sep 2022
    • Study sites: 18 to 23
    • Study completion date: Jun 2025 to Oct 2026
    • Eligibility criteria expanded, about 26 words
    v6
  7. Enrollment target: 162 to 500
    • Eligibility criteria revised
    • Site details revised at 1 of 18 sites
    v5
  8. Study sites: 16 to 18
    • Eligibility criteria expanded, about 2 words
    v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 16
    • Start date changed from estimate of Dec 2019 to Feb 5, 2020
    v3
  10. Study title shortened, about 5 wordsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Urotronic Inc.
6 trials monitored
See 1 trial at risk
PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)
Trial Details
NCT Number NCT04131907
Lead Sponsor Urotronic Inc.
Conditions
(from sponsor)		 Benign Prostatic Hyperplasia
Related terms Color Vision Defects, Prostatic Hyperplasia
Enrollment 162 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov