[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pulsatile-tinnitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pulsatile-tinnitus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,65,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100598330","bosstent-implantation-to-treat-pulse-synchronous-tinnitus-100598330",false,"NCT07070089","BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus","BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus","B-SILENT","Inclusion Criteria:\n\n1. Male or female ≥18 - 80 years old\n2. Able to provide informed consent to participate in the study\n3. Severe or catastrophic PST (THI grade ≥ 4; THI score ≥ 58) that responds to jugular vein compression.\n4. Cerebral venous sinus stenosis with the following characteristics:\n\n   1. Transverse cerebral venous sinus\n   2. \\>50% stenosis by computed tomography venogram (CTV), magnetic resonance venogram (MRV), or catheter cerebral angiography\n   3. Vessel diameter amenable to sizing according to Table 1 below without the need to undersize\n5. Attempted PST amelioration with at least one non-invasive therapy (i.e., refractory to non-invasive therapy)\n6. Willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up\n7. Life expectancy \\>12 months\n\nExclusion Criteria:\n\n1. Dural cerebral venous sinus stenosis secondary to an underlying condition (e.g. brain tumor) that may be treated by alternative established therapies (e.g., surgery, embolization)\n2. Previously implanted stent in the target vessel\n3. Contraindication to anticoagulant and\u002For antiplatelet therapy or thrombolytic drugs\n4. Target vessel size that does not fall within the indicated range per Table 1 of the IFU\n5. History of severe allergy to contrast\u002Fcontrast media or nickel\n6. Non-pulse-synchronous tinnitus\n7. Current diagnosis of papilledema\n8. Dural arteriovenous fistula or arteriovenous malformation\n9. History of untreated atrial fibrillation, untreated\u002Funcontrollable hypertension, or other stroke factors\n10. History of deep vein thrombosis or pulmonary embolism\n11. History of heart failure, dilated cardiomyopathy, or congenital heart conditions\n12. Arterial stenosis, dissection, or aneurysm\n13. PST due to causes not related to cerebral venous sinus stenosis\n14. Evidence of an active systemic infection\n15. Venous sinus thrombosis, jugular compression, venous aberrant or tortuous anatomy that would prevent the safe delivery and deployment of the BosSTENT to the target treatment zone.\n16. Cerebral venous sinus diverticulum that, in the Investigator's opinion, requires treatment other than stenting (e.g., coiling)\n17. Otologic disorders that may confound PST assessments, including, but not limited to misophonia or hyperacusis\n18. Hypercoagulable state or hemorrhagic or coagulation deficiency refractory to medical therapy\n19. Suffered a stroke within the past 6 months\n20. Platelet count \\\u003C100x109\u002FL (100,000\u002FµL)\n21. Participation in another investigational protocol\n22. Immuno-compromised\n23. Pregnant or nursing women (females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion)\n24. Other clinical conditions, that in the opinion of the Investigator significantly compromise the ability to perform a safe and\u002For effective procedure\n25. Incapacitated, mentally compromised or otherwise incapable of understanding and\u002For providing informed consent","ALL","18 Years","80 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is evaluating the safety and clinical performance of the BosSTENT, a new stent designed specifically for treating pulse-synchronous tinnitus due to venous sinus stenosis. The study will evaluate the long-term safety of the BosSTENT as well as its impact on the severity of pulse-synchronous tinnitus.",[28,29],"Pulsatile Tinnitus","Venous Sinus Stenosis","RECRUITING","2026-04-10",{"date":33,"type":34},"2026-04-15","ACTUAL",{"date":36,"type":34},"2026-02-01",{"date":38,"type":22},"2028-07",{"name":40,"class":41},"Sonorous NV, Inc","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100632599","vivastent-feasibility-study-100632599","NCT07515781","VivaStent Feasibility Study","Evaluation of the Safety and Feasibility of the VivaStent in Patients With Pulsatile Tinnitus Secondary to Ipsilateral Transverse-sigmoid Stenosis - The VivaStent Feasibility Study","Inclusion Criteria:\n\n* 1 Male or female ≥ 18 years of age at the time of screening. 2 An adult patient, experiencing pulsatile unilateral tinnitus for at least 1-year, which resolves with ipsilateral neck compression.\n\n  3 The patient suffers severe debilitating venous pulsatile tinnitus grade 4 or 5 according to the Tinnitus Handicap Inventory (Newman et al., 1996) 4 The patient has ≥50% stenosis of transverse-sigmoid sinus on the ipsilateral side to the pulsatile tinnitus, as identified by CTV or MRV.\n\n  5 The patient is a candidate for transverse-sigmoid sinuses stenting procedure using an off-label stent.\n\n  6 The patient is willing to sign an informed consent and participate in the study.\n\n  7 Intra-procedural criteria:Venographic confirmation of significant transverse-sigmoid sinus stenosis on the ipsilateral side of the pulsatile tinnitus.\n\n  • Pressure gradient ≥ 5 mm Hg, as measured by catheter manometry.\n\nExclusion Criteria:\n\n* 1 Presence of Dural Arteriovenous Fistula (AVF), cerebral vascular lesions, malformation, or aneurysm that can explain the pulsatile tinnitus on CTV or MRV.\n\n  2 Transverse-sigmoid sinus vessel size \\\u003C5 mm or \\>10 mm. 3 Anemia, defined as Hb \\\u003C 8 g\u002Fdl. 4 Chronic renal failure Creatinine \\> 1.6 mg\u002Fdl 5 History of stroke or transient ischemic attack (TIA). 6 History of severe carotid atherosclerotic disease. 7 History of AF or other stroke risk factors. 8 History of coagulopathy, hypercoagulability, deep vein thrombosis or pulmonary embolism.\n\n  9 History of severe chronic obstructive pulmonary disease (COPD) or other severe respiratory disease.\n\n  10 History of heart failure, dilated cardiomyopathy, or congenital heart conditions.\n\n  11 Pregnant (confirmed by a pregnancy test) or lactating woman 12 Otologic disorders, such as chronic hearing loss, or other ENT disorders that can cause tinnitus.\n\n  13 Allergic to iodinated contrast material despite premedication, or to Nitinol.\n\n  14 Contra-indication to aspirin, clopidogrel or other anticoagulants. 15 Protected adults, such as person subject to legal protection, person deprived of liberty, and person unable to express his consent.\n\n  16 Participating in another medical device or drug study.",{"count":51,"type":22},15,[25],"Subjects are enrolled in the study following signature of the Informed Consent Form and confirmation of eligibility criteria.\n\nDuring the screening\u002Fbaseline phase, demographic and clinical data, medical history, concomitant medications, available imaging (contrast-enhanced CTV or MRV), and THI and HIT-6 questionnaires are collected. Pre-procedural medication are initiated one week prior to the procedure, in accordance with standard medical practice.\n\nSubjects are admitted prior to the procedure according to local practice. Required laboratory tests, neurological assessments (modified Rankin Scale and NIHSS), and confirmation of informed consent are completed prior to any study-specific procedures.\n\nThe index procedure includes cerebral venography with confirmation of a significant transverse-sigmoid sinus stenosis and a pressure gradient greater than 5 mmHg. Following confirmation of procedural eligibility and appropriate vessel measurements, the VivaStent is deployed. Post-deployment venography and pressure measurements are performed to assess stent patency and hemodynamic outcome. Procedural data, administered medications, and adverse events are recorded.\n\nFollowing the procedure, subjects are hospitalized for observation as per local protocol. Prior to hospital discharge (or at Day 7 post-procedure, whichever occurs first), the THI questionnaire, concomitant medications, and adverse events are documented.\n\nFollow-up visits are conducted at 1 month, 3 months, and 12 months post-procedure. Each visit includes assessment of THI and HIT-6 questionnaires, documentation of concomitant medications and adverse events. Contrast-enhanced CTV or MRV is performed at the 3-month and 12-month visits to evaluate stent position and patency.\n\nSubject exit from the study is defined as completion of follow-up, subject withdrawal, investigator-initiated withdrawal, loss to follow-up, or death.",[28],"NOT_YET_RECRUITING","2026-03-31",{"date":58,"type":34},"2026-04-07",{"date":60,"type":22},"2026-04",{"date":62,"type":22},"2028-04",{"name":64,"class":41},"V-Flow 21",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100622474","the-diagnostic-accuracy-of-ankle-audiometry-performed-with-the-b250-for-superior-canal-dehiscence-syndrome-in-patients-affected-by-pulsatile-tinnitus-andor-autophony-disorders-100622474","NCT07384091","The Diagnostic Accuracy of Ankle Audiometry Performed With the B250 for Superior Canal Dehiscence Syndrome in Patients Affected by Pulsatile Tinnitus and\u002For Autophony Disorders","AA by B250","Inclusion Criteria:\n\n* Age between 18 and 64 years.\n* Patients with symptoms of autophony and\u002For pulsatile tinnitus either due to a confirmed diagnosis of SCDS or not due to SCDS.\n\nExclusion Criteria:\n\n* Severe sensorineural hearing.\n* Middle ear or ear canal pathologies.\n* Vulnerable patients.\n* Confirmed intolerance or contraindication for body (ankle) vibratory stimulation.\n* Anatomical body anomalies affecting normal testing procedure or interpretation of results.","64 Years",{"count":74,"type":22},30,[25],"The goal of this clinical trial is to learn if the ankle audiometry test performed with the B250 bone conduction transducer can identify patients with superior canal dehiscence syndrome from those without among subjects presenting with autophony (a hearing condition where you hear your own body sounds) and\u002For pulsatile tinnitus.\n\nThe main question it aims to answer:\n\n• Can ankle audiometry performed with B250 identify the condition of superior canal dehiscence syndrome among patients with autophony and\u002For pulsatile tinnitus, with a significance level of 80% and power level of 15%?\n\nStudy participants will undergo ankle audiometry testing with the B250 and the threshold in dB FL (at the ankle) for which the patient hears the sound in the target ear will be measured.",[78,79,28],"Superior Canal Dehiscence Syndrome","Autophony",[81,82,83],"SCDS","Ankle audiometry","B250","2026-01-26",{"date":86,"type":34},"2026-02-03",{"date":36,"type":22},{"date":89,"type":22},"2026-12-31",{"name":91,"class":92},"Region Stockholm","OTHER_GOV",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":93},"100491449","dural-sinus-stenting-of-low-grade-dural-arteriovenous-fistulae-davf-for-pulsatile-tinnitus-treatment-100491449","NCT05679271","Dural Sinus Stenting of Low Grade Dural Arteriovenous Fistulae (DAVF) for Pulsatile Tinnitus Treatment","Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study","INVENT","Inclusion Criteria:\n\n* Patient presenting invalidating pulsatile tinnitus\n* Patient presenting with PT anatomically correlated with a DAVF\n* Type I or IIa DAVF on digital subtraction angiography (DSA), according to Cognard's classification.\n* DAVF located on sigmoid , lateral or posterior longitudinal sinus.\n* Fistula length compatible with use of up to two stents\n* Highly effective contraception for women of childbearing potential, maintained during research procedures\n* Affiliated or beneficiary of health insurance\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient with DAVF not eligible for endovascular treatment .\n* DAVF classification of IIb or more according to Cognard's classification.\n* DAVF with severe sinus stenosis or occlusion judged as nor eligible for sinus stenting.\n* DAVF showing evidence of recent (inferior to 3 months) thrombophlebitis at the site of fistulous dural sinus.\n* Patient with DAVF previously treated with surgery or radiotherapy.\n* Patient with multiple DAVF\n* Controlateral sinus aplasia or occlusion\n* Patient presenting contra-indication to the use of LEA according to the instructions For Use.\n* Patient participating in another clinical study evaluating another medical device,\n* Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up as recommended by the study protocol at 6 months.\n* Patient with any known allergy to heparin, acetylsalicylic acid, Coumadin , Warfarin or other antiplatelet medications\n* Patient has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.\n* Patient has had an Intracranial hemorrhage and\u002For subarachnoid hemorrhage in the past 30 days prior to the study procedure\n* Known serious sensitivity to radiographic contrast agents.\n* Known sensitivity to nickel, titanium metals, or their alloys\n* Known renal failure as defined by a serum creatinine \\> 2.5 mg\u002Fdl (or 220 μmol\u002Fl) or glomerular filtration rate (GFR) \\\u003C 30.\n* Patient who has a contraindication to MRI or angiography for whatever reason\n* Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period\n* Patient unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent\n* Patient under legal protection",{"count":103,"type":22},48,[25],"The goal of this randomized trial to assess the angiographic efficacy of venous stenting in dural arteriovenous fistulae (DAVF) via improvment on Cognard's Classification as compared to no intervention at 6 months Participants belonging to experimental group will be treated using venous stenting. DAVF will be assessed by angiography at 6 months follow-up. Participants belonging to control group will be followed accordingly to standard of care (no treatment). After 6 months, control group patients can be treated by any means accordinlgly to standard of care.",[28],[108,109,110],"Dural arteriovenous fistulae","Pulsatile tinnitus","Venous Stenting","2025-02-07",{"date":113,"type":34},"2025-02-11",{"date":115,"type":34},"2024-08-22",{"date":117,"type":22},"2027-12",{"name":119,"class":120},"University Hospital, Bordeaux","OTHER"]