Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have a pulsating/whooshing sound in your ear (called pulsatile tinnitus) that significantly affects your daily life
• A scan has confirmed that your tinnitus is caused by an abnormal connection between arteries and veins near your brain, called a dural arteriovenous fistula (DAVF)
• Your DAVF is a mild type (Type I or IIa based on a standard medical classification system) as confirmed by a specialised blood vessel scan
• Your DAVF is located in a specific area at the back/side of the brain involving certain large blood vessels (the sigmoid, lateral, or posterior longitudinal sinus)
• The abnormal connection is small enough to be treated with no more than two small mesh tubes (stents)
• If you are a woman who could become pregnant, you must use reliable contraception throughout the study
• You are covered by health insurance
• You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

• Your DAVF cannot be treated through a minimally invasive procedure through the blood vessels
• Your DAVF is a more severe type (Type IIb or higher on the standard classification scale)
• Your DAVF involves a blood vessel that is too narrow or blocked to allow placement of a stent
• You have had inflammation or a blood clot in the affected blood vessel within the last 3 months
• Your DAVF has already been treated with surgery or radiation therapy
• You have more than one DAVF
• The large blood vessel on the opposite side of the head is absent or blocked
• You have a medical reason that prevents you from using the specific stent device used in this trial (confirm with trial site)
• You are currently taking part in another clinical study testing a medical device
• You are unable to attend follow-up appointments at the trial centre at 6 months
• You have a known allergy to heparin, aspirin, warfarin, or other blood-thinning or antiplatelet medications
• You have had any surgery or minimally invasive procedure in the 30 days before the study procedure
• You have had a bleed in or around your brain in the 30 days before the study procedure
• You have a known serious allergy to the dye used in medical scans (contrast agents)
• You have a known sensitivity or allergy to nickel, titanium, or related metals (which are used in the stent)
• You have significant kidney problems, as shown by specific blood test results (confirm with trial site for exact values)
• You have any reason that prevents you from having an MRI scan or blood vessel scan
• You are pregnant, breastfeeding, or planning to become pregnant during the study period
• You are unable to understand what the study involves or are unwilling to sign a consent form
• You are under legal guardianship or protection

Important: Always verify eligibility with the trial site directly before applying.