[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06930781":3,"trial-entities:NCT06930781":162,"trial-summary:NCT06930781":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":39,"sex":72,"minimum_age":73,"maximum_age":22,"healthy_volunteers":14,"eligibility_criteria":74,"std_ages":80,"locations":83,"central_contacts":148,"overall_officials":157,"references":160,"see_also_links":161},"NCT06930781","BC118","Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)","RECRUITING","2027-04-01","2026-07","2026-07-08","2025-05-07","Oticon Medical","INDUSTRY",false,"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.","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.",[18,19],"Hearing Loss","Bone Anchored Hearing Aids",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},270,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"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.",[33,34],"Prospective group","Retrospective group",[36],{"measure":37,"timeFrame":38},"Intraoperative complications at surgery","During the Ponto-implantation surgery",[40,44,48,52,56,60,63,65,69],{"measure":41,"description":42,"timeFrame":43},"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":45,"description":46,"timeFrame":47},"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":49,"description":50,"timeFrame":51},"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":53,"description":54,"timeFrame":55},"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":57,"description":58,"timeFrame":59},"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":61,"timeFrame":62},"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":64,"timeFrame":59},"To assess sound processor usage time",{"measure":66,"description":67,"timeFrame":68},"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":70,"description":71,"timeFrame":68},"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.","ALL","18 Years",{"inclusion":75,"exclusion":78,"raw_text":79},[76,77],"Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards","Signed informed consent (applicable for subjects answering questionnaires)",[],"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",[81,82],"ADULT","OLDER_ADULT",[84,99,108,122,131,140],{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"Northern California Veterans Affairs Healthcare System","Sacramento","California","95655","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Dr Lane Squires","CONTACT","916-734-5400","lane.squires@va.gov",{"lat":97,"lon":98},38.58157,-121.4944,{"facility":100,"status":101,"city":102,"state":102,"zip":103,"country":104,"geoPoint":105},"Clinical Hospital from the Ribeirão Preto Medical School","ACTIVE_NOT_RECRUITING","São Paulo","3900","Brazil",{"lat":106,"lon":107},-23.5475,-46.63611,{"facility":109,"status":7,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":119},"Queen Elizabeth II Health Sciences Centre","Halifax","Nova Scotia","B3H 2Y9","Canada",[115],{"name":116,"role":93,"phone":117,"email":118},"Dr David Morris","902-473-1986","DPMorrisENT@nshealth.ca",{"lat":120,"lon":121},44.64269,-63.57688,{"facility":123,"status":101,"city":124,"state":125,"zip":126,"country":127,"geoPoint":128},"Hospital Virgen de las Nieves","Granada","Andalusia","18014","Spain",{"lat":129,"lon":130},37.18817,-3.60667,{"facility":132,"status":101,"city":133,"state":134,"zip":135,"country":136,"geoPoint":137},"Sunderby Sjukhus","Luleå","Norrbotten County","971 80","Sweden",{"lat":138,"lon":139},65.58415,22.15465,{"facility":141,"status":101,"city":142,"state":143,"zip":144,"country":136,"geoPoint":145},"Skåne University Hospital","Lund","Skåne County","22185",{"lat":146,"lon":147},55.70584,13.19321,[149,153],{"name":150,"role":93,"phone":151,"email":152},"Sara Al-Dalal","+46 70-149 25 03","srld@oticonmedical.com",{"name":154,"role":93,"phone":155,"email":156},"Sara Svensson","+46735042041","ssve@oticonmedical.com",[158],{"name":116,"affiliation":109,"role":159},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":163,"biomarkers":164},[18],[],{"nct_id":4,"found":166,"summary":167,"prompt_version":177},true,{"design":168,"status":169,"heading":170,"summary":171,"follow_up":172,"word_count":173,"commitments":174,"compensation":175,"drugs_mentioned":176},"This is an observational, single-arm study that aims to include 270 participants. It combines looking back at past patient records and following new patients.","completed","Ponto Procedures Performed Outside the Main Operating Room","This study is looking at the safety of Ponto implantation, a surgical procedure to implant a bone-anchored hearing device, when it's done outside of a main operating room. Ponto implantation helps improve hearing by sending sound directly to the inner ear through bone. The main goal is to see how often complications happen during the surgery. You may be able to join if you are an adult (18 or older) having a Ponto implantation outside of a main operating room from 2019 onwards. This is an observational study, meaning researchers will watch what happens in real-world care. The current recruitment status is unclear.","Participants will be followed after surgery and during follow-up, after the sound processor is loaded.",103,"If you agree to participate, you would complete three questionnaires after surgery and during follow-up, after your sound processor is active.","Not stated in the trial record.",[30],"v2"]