RecruitingPHASE1, PHASE2INTERVENTIONAL

Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma

This study is testing a new treatment, VSF1.01, for people with severe hearing loss who are having a cochlear implant. A cochlear implant is a small electronic device that helps people to hear. The main goal is to find out if VSF1.01 is safe when put inside the ear during the implant surgery. Researchers also want to see if it helps reduce any damage to the inner ear during the operation. On top of that, they will check if VSF1.01 can improve things like how well people understand speech and their overall hearing after the implant. Participants will receive VSF1.01 during their standard cochlear implant surgery.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Hannover Medical School

Enrolment target

Start

18 Nov 2024

Estimated completion

01 Jun 2026

Hearing Loss

What is this study about?

This study is about making cochlear implant surgery even better for people with significant hearing loss. A cochlear implant is a wonderful tool that can help many people to hear. During the operation, a small device is carefully placed inside the inner ear.

The researchers are looking at a new treatment called VSF1.01. The idea is to apply this treatment inside the ear just before the implant is put in. They want to see if VSF1.01 can help protect the delicate parts of the inner ear during the surgery, potentially reducing any damage that might occur. This could lead to a smoother recovery and possibly even better hearing results in the long term.

The main thing the doctors want to check is if VSF1.01 is safe to use in this way. They will also be carefully monitoring whether it helps with things like how well the hearing nerve responds, if it improves understanding speech, and your general hearing ability, as well as how the implant itself works.

Key takeaways

This study evaluates a new treatment (VSF1.01) during cochlear implant surgery.
The main goal is to check if VSF1.01 is safe and helps protect the inner ear.
Researchers will also see if it improves hearing and speech understanding after the implant.
Participation involves receiving VSF1.01 during your planned cochlear implant operation.
You must have severe hearing loss and be eligible for a cochlear implant to join.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has been told you need a cochlear implant because of severe hearing loss. This includes people who might have some very low-frequency hearing but not enough to be useful.

There are certain reasons why you wouldn't be able to join. For example, if you've had previous ear surgery, have certain ear conditions like infections or unusual inner ear shapes, or have specific serious health issues affecting your kidneys, liver, or central nervous system. Also, if you are pregnant, breastfeeding, or have certain allergies, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe hearing loss and need a cochlear implant according to your doctor?
Have you not had any previous ear surgery?
Do you have any serious chronic kidney or liver problems?
Are you currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the VSF1.01 treatment during your standard cochlear implant operation. The surgery itself will be carried out in the usual way at the hospital. The study will involve regular check-ups to monitor your safety and how well your hearing is improving after the surgery. Doctors will look at how your hearing nerve responds, your ability to understand speech, and your overall hearing levels. They will also check how the implant electrodes are working. The total duration of your participation, including all follow-up appointments, will be explained to you by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit if VSF1.01 helps to protect your inner ear during surgery and improves your hearing results. However, like any treatment, there's always a possibility of risks, side effects, or that the treatment may not work as expected. The study team will explain all known or potential risks in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Hannover Medical School, Dept. of Otorhinolaryngology
Verified postcode
Hanover, Germany· Recruiting

Common questions

What is VSF1.01?

VSF1.01 is a new treatment being tested to see if it can protect the inner ear during cochlear implant surgery.

Will my cochlear implant surgery be different?

The surgery will be done as usual, but you will receive VSF1.01 inside your ear just before the implant is placed.

What kind of hearing loss do I need to have?

You need to have severe hearing loss and be a candidate for a cochlear implant.

Who cannot join this study?

People with certain medical conditions, previous ear surgeries, or who are pregnant/breastfeeding cannot join.

Will this improve my hearing straight away?

The study aims to see if it improves hearing over time and helps protect your ear during surgery. Results are not guaranteed.

How to find out more

Nils K. Prenzler, PD Dr.

prenzler.nils@mh-hannover.de +49(0)511 532 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.