[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549840":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":46,"locations":54,"responsibleParty":78,"collaborators":35,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":35,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":35,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University Ghent","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group: phonosurgery","EXPERIMENTAL","Group undergoing phonosurgery (glottoplasty, cricothyroid approximation, thyroplasty or chondrolaryngoplasty)",[13],"Procedure: Phonosurgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group: other surgery","ACTIVE_COMPARATOR","Control group: age matched TGD PFAB\u002FPMAB undergoing mastectomy or breast augmentation surgery with the same in- and exclusion criteria.",[19],"Procedure: Mastectomy\u002Fbreast augmentation",[21,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Phonosurgery","Gender-affirming voice surgery (such as glottoplasty, cricothyroid approximation, thyroplasty and chondrolaryngoplasty), in addition to gender-affirming voice training and hormone therapy, plays an important role in achieving a gender-congruent voice in transgender and gender diverse people. In addition, these interventions are sometimes performed on cisgender men or women who wish to change their voice. However, the impact of these interventions on broad voice characteristics needs to be further investigated.",[9],[27,28,29,30],"glottoplasty","thyroplasty","cricothyroid approximation","chondrolaryngoplasty",{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Mastectomy\u002Fbreast augmentation","Control group of PFAB and PMAB persons undergoing a mastectomy or breast augmentation surgery.",[15],null,[37,40,43],{"name":38,"affiliation":5,"role":39},"Clara Leyns, PhD","STUDY_DIRECTOR",{"name":41,"affiliation":5,"role":42},"Evelien D'haeseleer, PhD","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":42},"Peter Tomassen, PhD, MD","University Hospital, Ghent",[47,51],{"name":41,"role":48,"phone":49,"phoneExt":35,"email":50},"CONTACT","+32 9 332 24 67","evelien.dhaeseleer@ugent.be",{"name":38,"role":48,"phone":52,"phoneExt":35,"email":53},"+3293320143","clara.leyns@ugent.be",[55,71],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Ghent University Hospital","RECRUITING","Ghent","East-Flanders","9000","Belgium","BE",{"type":64,"coordinates":65},"Point",[66,67],3.71667,51.05,{"lat":67,"lon":66},[70],{"name":38,"role":48,"phone":35,"phoneExt":35,"email":53},{"facility":72,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Ghent University",{"type":64,"coordinates":74},[66,67],{"lat":67,"lon":66},[77],{"name":38,"role":48,"phone":35,"phoneExt":35,"email":53},{"type":79,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100549840","voice-outcome-of-glottoplasty-cricothyroid-approximation-thyroplasty-and-chondrolaryngoplasty-100549840",false,"NCT06439290","Voice Outcome of Glottoplasty, Cricothyroid Approximation, Thyroplasty, and Chondrolaryngoplasty","PURPOSE 1:\n\nInclusion criteria for surgery participants:\n\n* Persons who will soon undergo surgery on the vocal folds and\u002For larynx (including glottoplasty, cricothyroid approximation, thyroplasty and\u002For thyroid chondroplasty) at UZ Gent\n* At least 18 years old\n* Sufficient command of the Dutch language for understanding the informed consent letter and completing Dutch questionnaires\n\nInclusion criteria for volunteers to provide speech samples:\n\n\\- Cisgender men or women\n\nInclusion criteria for volunteer listeners for the listening experiment:\n\n* Dutch-speaking\n* Self-reported normal hearing\n\nPURPOSE 2: same as above.\n\nPURPOSE 3:\n\nInclusion criteria for the healthy participants:\n\n* At least 18 years old\n* Sufficient command of the Dutch language to complete a Dutch questionnaire\n\nExclusion criteria for the healthy participants:\n\n\\- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).\n\nInclusion criteria for the pre- and postoperative MRI participants:\n\n\\- Random selection of +- 10 participants of purpose 1.\n\nExclusion criteria for the pre- and postoperative MRI participants:\n\n\\- One or more contraindications for an MRI examination. These contraindications are checked using a questionnaire (safety checklist).",true,"ALL","18 Years","70 Years",{"count":91,"type":92},290,"ESTIMATED","INTERVENTIONAL",[95],"NA","The purpose of this study is to measure the short- and long-term voice outcome and outcome predictors of glottoplasty, cricothyroid approximation, thyroplasty, and chondrolaryngoplasty using a prospective non-randomized controlled trial and a multidimensional voice assessment protocol. Secondly, a laryngeal magnetic resonance imaging protocol will be developed to measure pre- and postoperative anatomical factors and compare them with the acoustic changes.",[98,99,100,101],"Surgery","Larynx","Transgenderism","Gender Dysphoria",[103,23,104,105],"Transgender","Determinants","MRI","2024-05-30",{"date":108,"type":109},"2024-06-03","ACTUAL",{"date":111,"type":109},"2024-04-10",{"date":113,"type":92},"2027-12",{"name":5,"class":6},2]