[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07579364":3,"trial-entities:NCT07579364":160,"trial-summary:NCT07579364":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":26,"primary_purpose":16,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":56,"locations":59,"central_contacts":137,"overall_officials":138,"references":142,"see_also_links":159},"NCT07579364","25-44455","Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery","ENROLLING_BY_INVITATION","2028-01","2026-05","2026-05-12","2025-10-28","University of California, San Francisco","OTHER",false,"The goal of this observational study is to learn about the long-term outcomes of Laryngeal Framework Surgery (LFS) in patients with Unilateral Vocal Fold Paralysis (UVFP) or Vocal Fold Atrophy (VFA). The main questions it aims to answer are:\n\n* Whether LFS technique (implant material, addition of arytenoid adduction) is associated with differences in outcomes such as complication rate, duration of surgery, hospital stay length, and quality of voice post-surgery.\n* Whether UVFP or VFA diagnosis is associated with differences in outcomes such as complication rate, duration of surgery, hospital stay length, and quality of voice post-surgery.\n\nParticipants who are determined by their clinician to need LFS for their UVFP or VFA will undergo the procedure, attend follow-up appointments, and complete surveys about their voice and swallowing ability as they would as part of their regular medical care.",null,[18,19],"Unilateral Vocal Cord Paralysis","Vocal Cord Atrophy",[21,22,23,24,25],"unilateral vocal fold paralysis","vocal fold atrophy","laryngeal framework surgery","arytenoid adduction","medialization thyroplasty","OBSERVATIONAL",[],{"count":29,"type":30},500,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Laryngeal Framework Surgery","All participants will receive laryngeal framework surgery as recommended by their treating surgeon. This can include medialization thyroplasty with or without arytenoid adduction, under general anesthesia or monitored anesthesia care.",[34],[25,24],[39],{"measure":40,"description":41,"timeFrame":42},"Change from baseline in the mean VHI-10 score at 12-months post operation","Voice Handicap Index-10 is a 10-item questionnaire used to measure voice handicap. Scores range from 0-40 with higher scores indicating greater voice handicap.","Baseline and 12 months",[],"ALL","18 Years",{"inclusion":47,"exclusion":52,"raw_text":55},[48,49,50,51],"Over 18 years of age","Diagnosed UVFP or VFA","English speaking","willing and able to follow up for 2 years",[53,54],"under 18","non-English speaking","Inclusion Criteria:\n\n* Over 18 years of age\n* Diagnosed UVFP or VFA\n* English speaking\n* willing and able to follow up for 2 years\n\nExclusion Criteria:\n\n* under 18\n* non-English speaking",[57,58],"ADULT","OLDER_ADULT",[60,69,76,82,90,98,106,114,122,129],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"University of California, San Diego","La Jolla","California","92093","United States",{"lat":67,"lon":68},32.84727,-117.2742,{"facility":70,"city":71,"state":63,"zip":72,"country":65,"geoPoint":73},"University of Southern California","Los Angeles","90033",{"lat":74,"lon":75},34.05223,-118.24368,{"facility":12,"city":77,"state":63,"zip":78,"country":65,"geoPoint":79},"San Francisco","94143",{"lat":80,"lon":81},37.77493,-122.41942,{"facility":83,"city":84,"state":85,"zip":86,"country":65,"geoPoint":87},"University of Miami","Miami","Florida","33136",{"lat":88,"lon":89},25.77427,-80.19366,{"facility":91,"city":92,"state":93,"zip":94,"country":65,"geoPoint":95},"Massachusetts Eye and Ear Infirmary","Boston","Massachusetts","02114",{"lat":96,"lon":97},42.35843,-71.05977,{"facility":99,"city":100,"state":101,"zip":102,"country":65,"geoPoint":103},"Washington University in St. Louis","St Louis","Missouri","63110",{"lat":104,"lon":105},38.62727,-90.19789,{"facility":107,"city":108,"state":109,"zip":110,"country":65,"geoPoint":111},"Wake Forest University","Winston-Salem","North Carolina","27101",{"lat":112,"lon":113},36.09986,-80.24422,{"facility":115,"city":116,"state":117,"zip":118,"country":65,"geoPoint":119},"University of Cincinnati","Cincinnati","Ohio","45267",{"lat":120,"lon":121},39.12711,-84.51439,{"facility":123,"city":124,"state":117,"zip":125,"country":65,"geoPoint":126},"Ohio State University","Columbus","43210",{"lat":127,"lon":128},39.96118,-82.99879,{"facility":130,"city":131,"state":132,"zip":133,"country":65,"geoPoint":134},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":135,"lon":136},32.77632,-79.93275,[],[139],{"name":140,"affiliation":12,"role":141},"Clark Rosen, MD","PRINCIPAL_INVESTIGATOR",[143,147,150,153,156],{"pmid":144,"type":145,"citation":146},"11603755","BACKGROUND","Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080\u002F000164800750000748.",{"pmid":148,"type":145,"citation":149},"33593469","Menon JR, Mathew AS, Nath S. Arytenoid asymmetry: Is it the most predictive parameter for arytenoid adduction in unilateral vocal fold paralysis? J Laryngol Otol. 2021 Feb;135(2):159-167. doi: 10.1017\u002FS0022215121000475. Epub 2021 Feb 17.",{"pmid":151,"type":145,"citation":152},"26485674","Siu J, Tam S, Fung K. A comparison of outcomes in interventions for unilateral vocal fold paralysis: A systematic review. Laryngoscope. 2016 Jul;126(7):1616-24. doi: 10.1002\u002Flary.25739. Epub 2015 Oct 20.",{"pmid":154,"type":145,"citation":155},"22075075","Stow NW, Lee JW, Cole IE. Novel approach of medialization thyroplasty with arytenoid adduction performed under general anesthesia with a laryngeal mask. Otolaryngol Head Neck Surg. 2012 Feb;146(2):266-71. doi: 10.1177\u002F0194599811427811. Epub 2011 Nov 10.",{"pmid":157,"type":145,"citation":158},"38365991","Mes SD, van der Jagt MA, Jansen JC, Langeveld APM, Sjogren EV, Heijnen BJ. Voice outcome in medialisation thyroplasty with and without arytenoid adduction: a prospective comparison using intraoperative voice measurements. Eur Arch Otorhinolaryngol. 2024 May;281(5):2499-2505. doi: 10.1007\u002Fs00405-024-08494-3. Epub 2024 Feb 17.",[],{"nct_id":4,"conditions":161,"biomarkers":164},[162,163],"Atrophy of vocal cord","Paralysis, Unilateral, Vocal Cord",[],{"nct_id":4,"found":14,"summary":16,"prompt_version":16}]