Europas førende søgning efter kliniske forsøg

Vsf1.01

Clinical trials are investigating Vsf1.01 in people with hearing loss who are receiving cochlear implantation. The study is looking mainly at safety and the number and severity of side effects after intracochlear injection during surgery. It is an early-phase trial in a small group of patients.

Table of contents

Trial overview

The authorised study ESCRT is an interventional clinical trial of Vsf1.01 in people with hearing loss who are receiving cochlear implantation.[1]

The full title states that the study looks at intracochlear application of Vsf1.01, which means it is given inside the cochlea during surgery.[1]

This trial includes 11 participants and is listed as Phase 1/2.[1]

Who can participate

The trial is designed for patients with hearing loss who are already receiving cochlear implantation.[1]

This means the study is not for all people with hearing loss, but for a small group in the setting of cochlear implant surgery.[1]

What is being studied

Researchers are studying Vsf1.01 as an adjuvant, which means it is used together with another treatment, here cochlear implantation.[1]

The study aims to see whether Vsf1.01 can help reduce surgery-related trauma, meaning tissue injury linked to the operation.[1]

Trial phase and design

This is a Phase 1/2 study, so it is an early clinical trial that first focuses on safety and also looks for early signals of possible benefit.[1]

The study is interventional, which means the research team gives the study treatment and then measures the results.[1]

Endpoints and what researchers measure

The primary endpoint is safety.[1]

To assess safety, the study records the number and severity of adverse events and serious adverse events.[1]

These are unwanted medical events that happen during the study, and the results are used to build a safety profile for Vsf1.01 in this setting.[1]

What this means for patients

For patients, this study is mainly about whether Vsf1.01 can be given safely during cochlear implant surgery.[1]

Because the trial is small and early, it is not yet meant to prove long-term benefit, but to gather first information on safety and how the treatment behaves in this surgical setting.[1]

Trial ID Phase Condition studied Status Enrollment
2024-512498-29-00 Phase 1/2 Hearing loss in patients receiving cochlear implantation Authorised 11

FAQ

  • What is Vsf1.01 being studied for in the trial? Vsf1.01 is being studied as an add-on treatment during cochlear implant surgery. The trial is focused on reducing surgery-related trauma and checking safety.
  • Who can take part in the study? The study is for patients with hearing loss who are receiving cochlear implantation. The trial includes a small group of 11 participants.
  • What phase is this clinical trial? This is a Phase 1/2 study. That means it is an early trial that first checks safety and also looks for early signs that the treatment may be useful.
  • What is the main goal of the trial? The main goal is to evaluate the safety of intracochlear injection of Vsf1.01. The study records the number and severity of adverse events, which are unwanted medical events.
  • What condition is being studied? The trial is studying hearing loss in the setting of cochlear implantation. It is not a general hearing loss study, but one linked to surgery.

Igangværende kliniske forsøg for Vsf1.01

  • Undersøgelse af VSF1.01-behandling under cochlear implantat-operation hos patienter med høretab

    Rekrutterer

    1 1
    Undersøgte lægemidler:
    Tyskland

Ordliste

  • Hearing loss: A reduced ability to hear. In this trial, it is the condition being studied in people who are having cochlear implant surgery.
  • Cochlear implantation: An operation that places a cochlear implant to help some people with severe hearing loss hear better.
  • Intracochlear injection: An injection placed inside the cochlea, which is a part of the inner ear.
  • Cochlea: A spiral-shaped part of the inner ear that helps process sound.
  • Adjuvant: A treatment given together with another treatment to support it. In this study, Vsf1.01 is used along with cochlear implantation.
  • Safety: How well a treatment is tolerated and whether it causes harmful effects.
  • Adverse event (AE): Any unwanted medical problem that happens during a study, whether or not it is caused by the treatment.
  • Serious adverse event (SAE): A more serious unwanted medical problem, such as one that causes major harm or needs urgent care.
  • Primary endpoint: The main result the researchers measure to answer the study question.
  • Phase 1/2: An early stage of clinical research that first checks safety and may also look for early signs of benefit.

Referencer

  1. https://clinicaltrials.gov/study/2024-512498-29-00