APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
This study is testing a new implant, the APrevent® VOIS, designed for adults aged 18 to 80 who have one paralysed vocal cord. When one vocal cord doesn't move, it can make your voice sound weak or breathy. The implant aims to improve this by helping the vocal cords close better. Researchers want to find out if the implant is safe to use and if it effectively improves people's voices. The study is split into two parts: first checking for safety in a small group, then looking at how well the implant works in a larger group. Participants will have check-ups over 12 months after the operation.
At a glance
What is this study about?
This study is looking at a new device called the APrevent® VOIS implant. It's designed for people who have a permanent problem where one of their vocal cords is paralysed. Your vocal cords are in your voice box (larynx) and they vibrate together to make sound when you speak. If one vocal cord doesn't move properly, it can lead to a weak, breathy, or hoarse voice, and sometimes difficulty swallowing or breathing.
The APrevent® VOIS implant is a small device that doctors hope can help the paralysed vocal cord move closer to the working one. This could help improve your voice by allowing the vocal cords to meet better when you try to speak. The implant is put in during a surgery called a thyroplasty, which is a common operation to improve voice problems.
The main goal of this study is to see if the APrevent® VOIS implant is safe for people to use and if it actually helps to improve their voice and daily life. The study will carefully follow people who receive the implant to understand its benefits and any potential problems. This research is important because it could offer a new way to help people with this challenging voice condition.
Key takeaways
- This study is testing a new implant for a paralysed vocal cord.
- It aims to improve voice quality for people with this condition.
- Participation involves an operation and follow-up appointments over one year.
- The study will check both the safety and effectiveness of the implant.
- Only people aged 18-80 with a specific type of vocal cord paralysis can join.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 80 years old and have a clear diagnosis of a permanently paralysed vocal cord on one side. Your voice problem needs to be significant enough to affect your daily life, as measured by special voice tests. You also need to understand exactly what the study involves, including any potential risks, and be able to commit to all the appointments and follow-up checks.
There are certain reasons why you wouldn't be able to join. For example, if you have other serious health conditions that might make participating risky, or if you've recently had certain treatments to your vocal cords that might interfere with the study results. You also can't take part if you have certain growths in your voice box, or if you have severe sleep apnoea. Women who are pregnant, breastfeeding, or planning to become pregnant also cannot participate.
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 between 18 and 80 years old?
- Have you been told you have one permanently paralysed vocal cord?
- Does your voice problem significantly affect your daily life?
- Are you able to attend several follow-up appointments over 12 months?
- Do you understand what being in a study involves and agree to follow the instructions?
What does participation involve?
If you decide to take part in this study, you will first go through a screening process to make sure you're a good fit. This will involve some tests and discussions about your health and voice. If you qualify, you will have an operation to place the APrevent® VOIS implant in your voice box. This is a surgical procedure, and your doctors will explain everything involved.
After the operation, you'll have several follow-up appointments. These visits are important for the doctors to check how you're recovering and how the implant is working. You'll have check-ups around 1 week, 7 weeks, 6 months, and 12 months after your surgery. During these visits, the medical team will assess your voice using special tests and ask about any changes you've noticed. The entire study will last for about 12 months from the time of your surgery.
Potential risks and benefits
Locations (7)
- Mayo Clinic - PhoenixVerified postcodePhoenix, United States· Recruiting
- Greater Baltimore Medical CenterVerified postcodeBaltimore, United States· Recruiting
- Cleveland ClinicVerified postcodeCleveland, United States· Not yet recruiting
- The University of Texas Health Science Center at HoustonVerified postcodeHouston, United States· Recruiting
- Medical University of ViennaVerified postcodeVienna, Austria· Recruiting
- SRH Wald-Klinikum GeraVerified postcodeGera, Germany· Recruiting
- University Medical CenterVerified postcodeHamburg, Germany· Recruiting
Common questions
What is a paralysed vocal cord?
It's when one of the two cords in your voice box doesn't move properly, making it hard to speak clearly.
What is the APrevent® VOIS implant?
It's a new small device designed to be placed in your voice box to help your vocal cords close better.
Will I need an operation for this study?
Yes, the implant is put in during a surgical procedure called a thyroplasty.
How long does the study last?
If you join, you'll be followed for about 12 months after your surgery.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time without giving a reason.
How to find out more
Berit Schneider-Stickler, Prof
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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