Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder
NCT03874780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2019-12-05
Summary
This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with overactive bladder.
Conditions
Interventions
- DEVICE
-
Vibe Delivery system
delivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system
Sponsors & Collaborators
-
Vensica Therapeutics Ltd.
lead INDUSTRY
Principal Investigators
-
Maya Shick · Consultant
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-29
- Primary Completion
- 2019-03-31
- Completion
- 2019-03-31
Countries
- Czechia
- Portugal
Study Locations
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