[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591104":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":32,"responsibleParty":161,"collaborators":163,"id":178,"slug":179,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":180,"sex":186,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":21,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Oticon Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sentio system","EXPERIMENTAL","Prospective, open label, single-arm multicentre investigation designed to follow clinical practice for bone conduction devices.",[13],"Device: Active transcutaneous bone conduction system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Active transcutaneous bone conduction system","The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.",[9],[9],null,[23,28],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Sara Svensson, MSc, PhD","CONTACT","+46 73 504 2041","ssve@oticonmedical.com",{"name":29,"role":25,"phone":30,"phoneExt":21,"email":31},"Marianne Philipsson, MSc","+46 70 098 1715","maph@oticonmedical.com",[33,53,68,85,100,116,134,149],{"facility":34,"status":35,"city":36,"state":21,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"University Medical Center Groningen","RECRUITING","Groningen","9700 RB","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],6.56667,53.21917,{"lat":44,"lon":43},[47,51],{"name":48,"role":25,"phone":49,"phoneExt":21,"email":50},"Myrthe K.S. Hol, MD, PhD","+31-6-18688531","m.k.s.hol@umcg.nl",{"name":48,"role":52,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":35,"city":55,"state":21,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Radboud University Medical Center","Nijmegen","6525EX",{"type":41,"coordinates":58},[59,60],5.85278,51.8425,{"lat":60,"lon":59},[63,67],{"name":64,"role":25,"phone":65,"phoneExt":21,"email":66},"Emmanuel A.M. Mylanus, MD, PhD","+31 024 361 49 34","Emmanuel.Mylanus@radboudumc.nl",{"name":64,"role":52,"phone":21,"phoneExt":21,"email":21},{"facility":69,"status":35,"city":70,"state":21,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Hospital Universitario de Donostia","San Sebastián","20014","Spain","ES",{"type":41,"coordinates":75},[76,77],-5.9,43.56667,{"lat":77,"lon":76},[80,84],{"name":81,"role":25,"phone":82,"phoneExt":21,"email":83},"Xabier Altuna Mariezcurrena, MD, PhD","+34607149431","xabier.altunamariezcurrena@osakidetza.eus",{"name":81,"role":52,"phone":21,"phoneExt":21,"email":21},{"facility":86,"status":35,"city":87,"state":21,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital Universitario Virgen Macarena","Seville","41009",{"type":41,"coordinates":90},[91,92],-5.97317,37.38283,{"lat":92,"lon":91},[95,99],{"name":96,"role":25,"phone":97,"phoneExt":21,"email":98},"Serafín Sánches Gómez, MD, PhD","+34 629 31 20 84","serafin.sanchez.sspa@juntadeandalucia.es",{"name":96,"role":52,"phone":21,"phoneExt":21,"email":21},{"facility":101,"status":35,"city":102,"state":21,"zip":103,"country":72,"countryCode":73,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"type":41,"coordinates":105},[106,107],-0.37966,39.47391,{"lat":107,"lon":106},[110,114],{"name":111,"role":25,"phone":112,"phoneExt":21,"email":113},"Carlos De Paula Vernetta, MD, PhD","+34 645 80 02 52","drcarlosdepaula@gmail.com",{"name":115,"role":52,"phone":21,"phoneExt":21,"email":21},"Carlos de Paula, MD, PhD",{"facility":117,"status":35,"city":118,"state":21,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Birmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust","Birmingham","B4 6NH","United Kingdom","UK",{"type":41,"coordinates":123},[124,125],-1.89983,52.48142,{"lat":125,"lon":124},[128,132,133],{"name":129,"role":25,"phone":130,"phoneExt":21,"email":131},"Ann-Louise McDermott, MD, PhD","+447779575889","ann-louise.mcdermott@nhs.net",{"name":21,"role":25,"phone":21,"phoneExt":21,"email":131},{"name":129,"role":52,"phone":21,"phoneExt":21,"email":21},{"facility":135,"status":35,"city":136,"state":21,"zip":137,"country":120,"countryCode":121,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"The Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust","London","SE1 7EH",{"type":41,"coordinates":139},[140,141],-0.12574,51.50853,{"lat":141,"lon":140},[144,148],{"name":145,"role":25,"phone":146,"phoneExt":21,"email":147},"Harry RF Powell, MD","+44 207 188 6245","harry.powell@gstt.nhs.uk",{"name":145,"role":52,"phone":21,"phoneExt":21,"email":21},{"facility":150,"status":35,"city":136,"state":21,"zip":151,"country":120,"countryCode":121,"cosmosGeoPoint":152,"geoPoint":154,"contacts":155},"Great Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust","WC1N 3JH",{"type":41,"coordinates":153},[140,141],{"lat":141,"lon":140},[156,160],{"name":157,"role":25,"phone":158,"phoneExt":21,"email":159},"Robert Nash, MD","+447701040515","Robert.Nash@gosh.nhs.uk",{"name":157,"role":52,"phone":21,"phoneExt":21,"email":21},{"type":162,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[164,167,169,171,172,173,175,176],{"name":165,"class":166},"Guy's and St Thomas' NHS Foundation Trust","OTHER",{"name":168,"class":166},"Birmingham Women's and Children's NHS Foundation Trust",{"name":170,"class":166},"Great Ormond Street Hospital for Children NHS Foundation Trust",{"name":34,"class":166},{"name":54,"class":166},{"name":174,"class":166},"Hospital Universitario La Fe",{"name":86,"class":166},{"name":177,"class":166},"Hospital Donostia","100591104","pediatric-expansion-study-of-the-sentio-system-100591104",false,"NCT06976086","Pediatric Expansion Study of the Sentio System","A Prospective, Multicenter, Single-arm Clinical Investigation of the Safety and Performance of the Sentio System in a Pediatric Population","BC119","Inclusion Criteria:\n\n1. Signed Informed Consent Form (depending on age of child, signed by parent or legal guardian and child)\n2. Subject aged 3 to 11 years\n3. Subject with:\n\n   3.1 conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL.\n\n   3.2 OR subject who has a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3 OR subject indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.\n4. Subject and parent or legal guardian have the ability and willingness to comply with investigational procedures\u002F requirements, as determined by the investigator.\n5. Subject with prior experience of amplified sound through a properly fitted hearing aid, a CROS device, or a non-surgical bone anchored solution (e.g. softband).\n6. For subject with conductive or mixed hearing losses, ensure sufficient air bone gap (ABG) at the ear to be implanted.\n7. Sufficient bone quality\u002Fquantity\u002Fdepth or skull size for implantation of a Sentio Ti implant as assessed according to clinical practice.\n\nExclusion Criteria:\n\n1. Medical condition that contraindicates implant surgery or anesthesia as judged by the investigator.\n2. Untreated ongoing middle ear infection at the time of surgery.\n3. Known or suspected contact allergy to silicone or other material used in the Sentio system.\n4. Known condition that could jeopardize wound healing and skin condition, e.g. uncontrolled diabetes over time, as judged by the investigator.\n5. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor.\n6. Evidence of conditions that would prevent good speech recognition potential as determined by good clinical judgment.\n7. Any other known condition that the investigator determines could interfere with compliance or investigation assessments.\n8. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator.\n9. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period.\n10. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds.\n11. Known chronic or non-revisable vestibular or balance disorder.\n12. Known abnormally progressive hearing loss.\n13. Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Sentio system as determined by the investigator.\n14. Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as CSF shunts, implantable cardiac pacemakers, defibrillators, or neurostimulators.\n15. Known need for frequent MRI investigations for follow-up of other diseases.\n16. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.","ALL","3 Years","11 Years",{"count":190,"type":191},50,"ESTIMATED","INTERVENTIONAL",[194],"NA","This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.",[197,198,199],"Hearing Loss, Conductive","Hearing Loss, Mixed","Single Sided Deafness",[9,201,202,203,204,205],"Paediatric","Hearing loss","Children","Bone conduction","Transcutaneous","2026-01-09",{"date":208,"type":209},"2026-01-12","ACTUAL",{"date":211,"type":209},"2025-04-30",{"date":213,"type":191},"2027-07-01",{"name":5,"class":6},8]