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Clinical Trial for the Assessment of Safety, Usability and Efficacy of the Vixe Combination for OAB in Female Subjects

NCT06345677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-04-09

No results posted yet for this study

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 question\[s\] 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.

Conditions

Interventions

COMBINATION_PRODUCT

ViXe Xombination

Combination of Xeomin and the ultrasound based delivery system (Vibe) for intravesical administration of the drug in a minimally invasive procedure

COMBINATION_PRODUCT

Placebo + Sham

Placebo identical in package and appearance to Xeomin together with all steps of Vibe device preparation and activation, but without the actual operation of the ultrasound energy

Sponsors & Collaborators

  • Blueclinical, Ltd.

    collaborator OTHER

  • Vensica Therapeutics Ltd.

    lead INDUSTRY

Principal Investigators

  • Palma dos Reis, Dr · Principal investigator at CHLN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

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 NCT06345677 on ClinicalTrials.gov