Akyva First In Human

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.

NCT Number	NCT06956209
Lead Sponsor	Iota Biosciences, Inc Collaborators: Astellas Pharma Inc, H&A LifeSciences Pty Ltd
Conditions	Underactive Bladder
Enrollment	15 participants
Start Date	2025-09-24
Primary Completion	2028-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-15