Table of Contents
- Trial overview
- Who is being studied
- Study design and phase
- What the trial measures
- What this study may mean for patients
Trial overview
The available clinical trial is titled Intracochlear application of Vsf1.01 for the reduction of cochlear implant surgery related trauma, also called the ESCRT study.[1]
This study is testing Vsf1.01 as an added treatment during cochlear implant surgery, with the medicine given by intracochlear injection, which means an injection placed directly into the cochlea.[1]
The trial is authorised and planned as an interventional study, so researchers actively give the study treatment and then observe what happens.[1]
Who is being studied
The trial is for patients with hearing loss who are receiving cochlear implantation.[1]
The source data do not list more detailed inclusion or exclusion rules, so the exact participation criteria are not available here.[1]
The planned enrollment is 11 people, which means this is a very small early study.[1]
Study design and phase
This is a Phase 1/2 trial, which is an early stage of clinical research.[1]
Early phase studies usually focus on safety first and may also give early information that can guide future research.[1]
The study is described as interventional, meaning the researchers are testing a treatment rather than only observing patients.[1]
What the trial measures
The main goal of the study is to assess safety of Vsf1.01 when used during cochlear implantation.[1]
The primary endpoint is the number and severity of adverse events and serious adverse events, which are medical problems that happen during the study and are carefully recorded.[1]
These safety results are meant to create a safety profile for Vsf1.01 in this surgical setting.[1]
What this study may mean for patients
For patients, this trial is mainly about learning whether Vsf1.01 can be used safely during cochlear implant surgery.[1]
Because the study is small and early, it is not designed to prove long-term benefit, but to collect first safety data in people with hearing loss who need cochlear implants.[1]
The study focus on surgery related trauma shows that researchers are looking at whether the treatment may help reduce injury linked to the implant procedure.[1]
