Status:
ACTIVE_NOT_RECRUITING
Augmenting Urinary Reflex Activity: Study 3
Lead Sponsor:
Amber Therapeutics Ltd
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.
Eligibility Criteria
Inclusion
- Participant has exited the AURA-2 clinical investigation.
- Participant has an implanted Amber UI system.
- Consents to participation.
Exclusion
- Participant has withdrawn from AURA-2 clinical investigation.
- Participant is pregnant.
- A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06597994
Start Date
January 15 2025
End Date
January 1 2026
Last Update
May 15 2025
Active Locations (1)
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1
University Hospital Antwerp
Antwerp, Belgium, 2650