In short
Clinical trials are investigating Vsf1.01 in people with hearing loss who are receiving cochlear implants. The main goal is to check safety and record side effects after intracochlear injection during surgery. This research is in an early phase and includes a small group of patients.
Key points
- Clinical trials of Vsf1.01 are focused on patients with hearing loss who are having cochlear implantation. The available study is an early Phase 1/2 interventional trial. It tests Vsf1.01 as an intracochlear injection, meaning it is placed directly into the cochlea during surgery. The main purpose is safety, including recording the number and severity of adverse events. The trial is authorised and plans to include 11 participants.
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.
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.
The trial is authorised and planned as an interventional study, so researchers actively give the study treatment and then observe what happens.
Who is being studied
The trial is for patients with hearing loss who are receiving cochlear implantation.
The source data do not list more detailed inclusion or exclusion rules, so the exact participation criteria are not available here.
The planned enrollment is 11 people, which means this is a very small early study.
Study design and phase
This is a Phase 1/2 trial, which is an early stage of clinical research.
Early phase studies usually focus on safety first and may also give early information that can guide future research.
The study is described as interventional, meaning the researchers are testing a treatment rather than only observing patients.
What the trial measures
The main goal of the study is to assess safety of Vsf1.01 when used during cochlear implantation.
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.
These safety results are meant to create a safety profile for Vsf1.01 in this surgical setting.
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.
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.
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.