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Akyva First In Human

NCT06956209 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

  • Underactive Bladder

Interventions

DEVICE

Direct Bladder Wall Stimulation

The Akyva System is an implantable device intended to electrically stimulate the bladder muscle that controls bladder emptying or urination

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • H&A LifeSciences Pty Ltd

    collaborator UNKNOWN

  • Iota Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Carmela Cusumano, MS, CCRP, CMDA · Iota Biosciences

  • Mike Woods, MD · iota Biosciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-24
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06956209 on ClinicalTrials.gov