Active not recruitingNAINTERVENTIONAL

Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement

This study is looking into a new device called the SPIRION Laryngeal Pacemaker for people who have noisy or difficult breathing because their vocal cords are paralysed. This condition is known as Bilateral Vocal Cord Paralysis (BVFP). The main goals of the study are to find out if the device is safe to use and if it improves patients' ability to breathe. Participants will have the SPIRION Laryngeal Pacemaker surgically placed, and then their symptoms and progress will be carefully watched for up to two years. This device is designed to gently stimulate a muscle in the throat to help open up the airway, making breathing easier. The results will help determine if this device can be made available more widely.

At a glance

Status

Active not recruiting

Phase

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Enrolment target

Start

27 Jul 2023

Estimated completion

01 Dec 2028

Bilateral Vocal Cord Paralysis

What is this study about?

This medical study is designed to explore a new device called the SPIRION Laryngeal Pacemaker. This device is specifically for people who have a condition called Bilateral Vocal Cord Paralysis (BVFP). In this condition, both vocal cords become paralysed, which can make breathing very difficult and noisy, sometimes even requiring surgery to help. The main purpose of the study is to understand if this new pacemaker is safe to use and if it helps people breathe more easily. The device works by gently stimulating a small muscle in your throat, which in turn helps to open up your airway, improving your breathing.

The SPIRION Laryngeal Pacemaker has three main parts: two small parts that are placed under your skin, and one external part that you wear on your skin, over your chest. The external part sends signals to the internal parts, which then send a gentle electrical pulse to the throat muscle. This pulse encourages the vocal cord to move outwards, creating a wider space for air to pass through.

This study is an important step in assessing new medical technologies. The information gathered from participants will help the manufacturers, MED-EL, to understand the long-term safety and effectiveness of the device. This is crucial for gaining approval for the device to be used more widely in Europe, giving more people with severe breathing difficulties due to BVFP a potential new treatment option.

Key takeaways

This study evaluates a new device for severe breathing issues from vocal cord paralysis.
The SPIRION Pacemaker aims to improve breathing by electrically stimulating a throat muscle.
Participation involves surgery for device implantation and follow-up for up to 28 months.
The study assesses both the safety and effectiveness of the device.
It's a step towards potential new treatments for this condition.

Who may be eligible?

To join this study, participants generally need to be between 18 and 75 years old and have been diagnosed with Bilateral Vocal Cord Paralysis (BVFP) for at least six months. It's important that your breathing is strong enough to live independently, even without the pacemaker, especially before any existing breathing tubes (tracheostomies) are considered for removal during the study.

Researchers will also check if a specific throat muscle can respond to electrical stimulation, as this is how the pacemaker works. You can't be pregnant or breastfeeding, and you shouldn't have ongoing throat infections. Also, certain other throat conditions, previous surgeries that might interfere with the device, or very recent treatments like Botox in your vocal cords, would mean you can't take part. You also need to be able to speak German.

Patients who have previously been involved in an earlier study for this device, or those who currently have a breathing hole in their neck (tracheostoma), could also be considered for this study if they meet all other criteria.

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 75 years old?
Have you been diagnosed with vocal cord paralysis in both vocal cords for at least 6 months?
Can you breathe sufficiently on your own, even without the pacemaker helping?
Does at least one of your key throat muscles respond to electrical stimulation?
Are you not pregnant or breastfeeding?
Have you had significant previous throat surgeries or currently have an infection?

Answer every question to see your result.

What does participation involve?

If you are interested in this study, your ear, nose, and throat doctor would first tell you more about it. If you decide you'd like to proceed, you'll go through a detailed process to make sure you fully understand what's involved and agree to take part. This is called 'informed consent'. Next, you'll be checked to see if you meet all the study requirements. If you do, the medical team will record your current breathing, voice, and other symptoms.

A few days or weeks later, the SPIRION Laryngeal Pacemaker will be surgically placed. The device will then be switched on and adjusted to your individual needs about 3 to 5 weeks after your surgery. After that, you'll have several follow-up visits with the study team at specific times: after about 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months, leading up to a maximum of 28 months of active participation.

Potential risks and benefits

Potential benefits of taking part include the chance of improving your breathing difficulties caused by vocal cord paralysis and potentially experiencing a better quality of life. You would also be helping to advance medical knowledge and offer a new treatment option for others. As with any medical procedure, there are potential risks associated with surgery and the device itself, such as infection or issues with the implant. The medical team will explain all known risks to you in detail. It's important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Tirol Kliniken GmbH
Verified postcode
Innsbruck, Austria
Medical University of Vienna
Verified postcode
Vienna, Austria
Stuttgart Hospital - Katharinenhospital
Verified postcode
Stuttgart, Germany
University Hospital of Würzburg
Verified postcode
Würzburg, Germany
SRH Wald-Klinikum Gera GmbH
Verified postcode
Gera, Germany
Charité - Medical University of Berlin
Verified postcode
Berlin, Germany

Common questions

What is Bilateral Vocal Cord Paralysis (BVFP)?

It's a condition where both of your vocal cords are paralysed, which can make it hard to breathe properly and cause noisy breathing.

What does the SPIRION Laryngeal Pacemaker do?

It's a new device that uses gentle electrical pulses to stimulate a throat muscle, helping to open your airway and make breathing easier.

How long will I be involved in the study?

If you join, you could be actively involved in the study for up to 28 months, which is just over two years.

Will I have surgery?

Yes, the pacemaker has parts that are implanted under your skin, so you will need to have surgery to place them.

Can I stop participating if I change my mind?

Yes, you are free to leave the study at any time without having to give a reason, and it won't affect your medical care.