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Akyva First In Human

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 37 wordsv9
  2. Site details revised at 1 of 2 sitesv8
  3. Primary endpoint(s) modified
    • Eligibility criteria shortened, about 219 words
    • Secondary endpoints revised (2)
    • Study sites revised (2)
    v7
  4. Enrollment target: 10 to 15v6 Show 4 more changesShow less
    • Primary and study completion dates: Mar 2027 to Sep 2028
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints: details revised at 2 of 2 entries
  5. Eligibility criteria expanded, about 78 words
    • Secondary endpoints: details revised at 2 of 2 entries
    v5
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2025 to Sep 24, 2025
    • Site details revised
    v4
  2. 2 versions Re-verified since May 20, 2025, no change to tracked fieldsv2-v3
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this study is to check if the study device, the Akyva System, is safe to use and to find out if it has any possible side effects. Researchers will see if the study device can help you urinate without the need for catheterization, which involves passing a catheter (small tube) into the bladder, and if there is improvement in the leftover urine amount in your bladder after urinating or trying to urinate.
Trial Details
NCT Number NCT06956209
Lead Sponsor Iota Biosciences, Inc
Collaborators: Astellas Pharma Inc, H&A LifeSciences Pty Ltd
Conditions
(from sponsor)		 Underactive Bladder
Related terms Urinary Bladder, Underactive
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov