Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345677
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-02-20
Brief Title:
Clinical Trial for the Assessment of Safety Usability and Efficacy of the Vixe Combination for OAB in Female Subjects
Sponsor:
Vensica Therapeutics Ltd
Organization:
Vensica Therapeutics Ltd
Study Overview
Official Title:
An Exploratory Prospective Multicenter Randomized Double Blind Placebo Sham Device Controlled Study to Assess the Safety Usability and Initial Efficacy of the ViXe Combination for Intravesical Administration of XEOMIN in the Treatment of Female Patients With Idiopathic Overactive Bladder OAB
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
XAVIER
Brief Summary:
The goal of this interventional clinical trial is to assess the safety usability and initial efficacy of Xeomin and Vibe combination ViXe compared to placebo sham in female subjects with idiopathic Overactive Bladder The main questions it aims to answer are The rate of device and drug related serious adverse events during treatment and throughout the follow up period Investigator subject and technician satisfaction from treatment and Assess the initial efficacy of the drug-device combination compared to placebo-sham combination Participants will be treated a single time with the ViXe combination and will be followed up for a period of 12 weeks during which they will visit the clinic after 2 6 and 12 weeks Participants will complete a 3-day voiding diary prior to the 6- and 12-week FU visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None