Clinical Trials Directory

Trials / Completed

CompletedNCT03874780

Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder

First in Human (FIH) Study for the Evaluation of the Safety and Early Performance of the Vibe Delivery System for the Delivery of Botox™ in Subjects With Idiopathic Overactive Bladder (OAB)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Vensica Therapeutics Ltd. · Industry
Sex
Female
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICEVibe Delivery systemdelivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system

Timeline

Start date
2019-01-29
Primary completion
2019-03-31
Completion
2019-03-31
First posted
2019-03-14
Last updated
2019-12-05

Locations

2 sites across 2 countries: Czechia, Portugal

Source: ClinicalTrials.gov record NCT03874780. Inclusion in this directory is not an endorsement.