[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587622":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":48,"studyPopulation":49,"armGroups":50,"interventions":60,"overallOfficials":66,"centralContacts":71,"locations":81,"responsibleParty":120,"collaborators":11,"id":122,"slug":11,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":11,"eligibilityCriteria":126,"healthyVolunteers":123,"sex":127,"minAge":128,"maxAge":11,"enrollmentInfo":129,"targetDuration":11,"studyType":132,"phases":11,"briefSummary":133,"conditions":134,"keywords":11,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Oticon Medical","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Intraoperative complications at surgery",null,"During the Ponto-implantation surgery",[14,18,22,26,30,34,37,39,43],{"measure":15,"description":16,"timeFrame":17},"Assessment of procedure room variables","To make an assessment of how procedure rooms that are used for Ponto out-of-OR surgeries look like. Will be measured using the 'Procedure room used for Out-of-OR Ponto-surgery questionnaire'","12 months after study start",{"measure":19,"description":20,"timeFrame":21},"To assess surgical parameters","With this outcome, the aim is to assess the surgical variables present during Ponto out-of-OR surgeries. A series of yes or no questions will be presented in a form to the surgeon regarding the use of anesthesia, sedatives, implants, and abutments of different lengths. The results will be presented in a table.","During Ponto-implantation surgery",{"measure":23,"description":24,"timeFrame":25},"Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire","Score is reported on a scale of 5 steps, were the lowest value (1) is the worst and the highest value is the best (5)","5-10 days after Ponto surgery",{"measure":27,"description":28,"timeFrame":29},"To assess postoperative events and complications","All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication.","From day of surgery, through study completion, an average of 1 year",{"measure":31,"description":32,"timeFrame":33},"To assess rate of implant survival","Implant survival will be assessed at least once, at 3 months. If follow-up data is available, implant survival will be assessed through study completion, an average of 1 year.","3 months after surgery, and through study completion, an average of 1 year.",{"measure":35,"description":11,"timeFrame":36},"To assess time from surgery to sound processor loading","Time from surgery to sound processor loading which happens at an average of 3 months after surgery.",{"measure":38,"description":11,"timeFrame":33},"To assess sound processor usage time",{"measure":40,"description":41,"timeFrame":42},"To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire","Will be assessed using the standardised questionnaire International Outcome Inventory for Hearing Aids (IOI-HA) score at 3 months post-surgery. In the questionnaire, each item has five response choices proceeding from the worst outcome to the best outcome (1-5). The score will be presented as mean score with, standard deviation and median for the two groups.","3 months after surgery",{"measure":44,"description":45,"timeFrame":42},"To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI)","Glasgow Benefit Inventory (GBI) benefit scores will be presented for total-, general-, social- and physical scores at 3 months post-surgery. The GBI uses a scale from -100 to +100, where scores above 0 indicate improved quality of life.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":47,"timePerspective":47,"maskingInfo":11},"OTHER","The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.\n\nThe study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.","Bone-conduction hearing device users",[51,56],{"label":52,"type":11,"description":53,"interventionNames":54},"Retrospective group","Data gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards",[55],"Device: Ponto implantation",{"label":57,"type":11,"description":58,"interventionNames":59},"Prospective group","Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires.",[55],[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"DEVICE","Ponto implantation","Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.",[57,52],[67],{"name":68,"affiliation":69,"role":70},"Dr David Morris","Queen Elizabeth II Health Sciences Centre","PRINCIPAL_INVESTIGATOR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":11,"email":76},"Sara Al-Dalal","CONTACT","+46 70-149 25 03","srld@oticonmedical.com",{"name":78,"role":74,"phone":79,"phoneExt":11,"email":80},"Sara Svensson","+46735042041","ssve@oticonmedical.com",[82,103],{"facility":83,"status":84,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Sunderby Sjukhus","RECRUITING","Luleå","Norrbotten County","971 80","Sweden","SE",{"type":91,"coordinates":92},"Point",[93,94],22.15465,65.58415,{"lat":94,"lon":93},[97,101],{"name":98,"role":74,"phone":99,"phoneExt":11,"email":100},"Dr Rönnblom","+46 703 773 666","anton.ronnblom@norrbotten.se",{"name":102,"role":70,"phone":11,"phoneExt":11,"email":11},"Anton Rönnblom",{"facility":104,"status":84,"city":105,"state":106,"zip":107,"country":88,"countryCode":89,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Skåne University Hospital","Lund","Skåne County","22185",{"type":91,"coordinates":109},[110,111],13.19321,55.70584,{"lat":111,"lon":110},[114,118],{"name":115,"role":74,"phone":116,"phoneExt":11,"email":117},"Dr Gisselsson-Solén","+46 46-172815","Marie.Gisselsson-Solen@skane.se",{"name":119,"role":70,"phone":11,"phoneExt":11,"email":11},"Marie Gisselsson-Solén",{"type":121,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100587622",false,"NCT06930781","Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)","Inclusion Criteria:\n\n* Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards\n* Signed informed consent (applicable for subjects answering questionnaires)\n\nExclusion Criteria:\n\n* No exclusion criteria have been set for this observational investigation","ALL","18 Years",{"count":130,"type":131},270,"ESTIMATED","OBSERVATIONAL","This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.",[135,136],"Hearing Loss","Bone Anchored Hearing Aids","2025-05-16",{"date":139,"type":140},"2025-05-18","ACTUAL",{"date":142,"type":140},"2025-05-07",{"date":144,"type":131},"2026-12-01",{"name":5,"class":6},2]