[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470380":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":121,"collaborators":25,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":25,"enrollmentInfo":133,"targetDuration":25,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":49,"whyStopped":25,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Queen Mary University of London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Thermal ablation of adrenal aldosterone producing adenoma (s)","EXPERIMENTAL","For patients randomized to ablation, thermal ablation (either microwave or radiofrequency ablation) will be deployed to treat the adrenal aldosterone producing adenoma(s)",[13],"Procedure: Thermal ablation of aldosterone producing adenoma.",{"label":15,"type":6,"description":16,"interventionNames":17},"Unilateral adrenalectomy for aldosterone producing adenoma (s)","For patients randomized to surgery, unilateral adrenalectomy will be performed to remove aldosterone producing adenoma(s)",[18],"Procedure: Unilateral adrenalectomy",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Thermal ablation of aldosterone producing adenoma.","On the left side, Radiofrequency ablation of aldosterone producing adenoma(s) will be undertaken via the stomach (endoscopically), under transgastric ultrasound guidance.\n\nOn the right side, either Radiofrequency or Microwave Ablation of aldosterone producing adenoma(s) will be performed via a percutaneous approach, under CT guidance.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Unilateral adrenalectomy","Unilateral total adrenalectomy for aldosterone producing adenoma. This will be laparoscopic in the vast majority of patients, with open conversion if surgically indicated (unlikely in \\>1-2 patients)",[15],[31],"Laparoscopic adrenalectomy",[33],{"name":34,"affiliation":5,"role":35},"Morris Brown","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Aklima Khatun","CONTACT","0203 765 8577","aklima.khatun4@nhs.net",{"name":43,"role":39,"phone":44,"phoneExt":25,"email":45},"Tumi Kaminsas","0207 882 5994","research.governance@qmul.ac.uk",[47,65,78,88,98,108],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Cambridge University Hospitals NHS Foundation Trust","RECRUITING","Cambridge","SMLG","CB2 0QQ","United Kingdom","UK",{"type":56,"coordinates":57},"Point",[58,59],0.11667,52.2,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":25,"phoneExt":25,"email":64},"Prof Mark Gurnell","mg299@medschl.cam.ac.uk",{"facility":66,"status":49,"city":67,"state":25,"zip":68,"country":53,"countryCode":54,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"St Bartholomew's Hospital","London","EC1A 7BE",{"type":56,"coordinates":70},[71,72],-0.12574,51.50853,{"lat":72,"lon":71},[75],{"name":76,"role":39,"phone":25,"phoneExt":25,"email":77},"Prof William Drake, FRCP DM","w.m.drake@qmul.ac.uk",{"facility":79,"status":49,"city":67,"state":25,"zip":80,"country":53,"countryCode":54,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"University College London Hospital NHS Foundation Trust","NW1 2PG",{"type":56,"coordinates":82},[71,72],{"lat":72,"lon":71},[85],{"name":86,"role":39,"phone":25,"phoneExt":25,"email":87},"Dr Teng-Teng Chung","teng-teng.chung@nhs.net",{"facility":89,"status":49,"city":67,"state":25,"zip":90,"country":53,"countryCode":54,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Guy's and St Thomas' NHS Foundation Trust","SE1 9RT",{"type":56,"coordinates":92},[71,72],{"lat":72,"lon":71},[95],{"name":96,"role":39,"phone":25,"phoneExt":25,"email":97},"Dr Paul Carroll","paul.carroll@gstt.nhs.uk",{"facility":99,"status":49,"city":67,"state":25,"zip":100,"country":53,"countryCode":54,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"Imperial College Healthcare NHS Trust","W12 0HS",{"type":56,"coordinates":102},[71,72],{"lat":72,"lon":71},[105],{"name":106,"role":39,"phone":25,"phoneExt":25,"email":107},"Dr Florian Wernig","fwernig@nhs.net",{"facility":109,"status":49,"city":110,"state":25,"zip":111,"country":53,"countryCode":54,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Sheffield Teaching Hospitals NHS Foundation Trust","Sheffield","S10 2JF",{"type":56,"coordinates":113},[114,115],-1.4659,53.38297,{"lat":115,"lon":114},[118],{"name":119,"role":39,"phone":25,"phoneExt":25,"email":120},"Dr Sam O' Toole","samuel.otoole@nhs.net",{"type":122,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100470380","randomised-trial-comparing-thermal-ablation-with-adrenalectomy-in-the-treatment-of-unilateral-asymmetric-pa-100470380",false,"NCT05405101","Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA","A Prospective Randomised Trial Comparing Thermal Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism","WAVE","Inclusion criteria (all of):\n\n* Age \\> 18 years\n* Primary aldosteronism diagnosed according to international guidelines\n* Unilateral disease by AVS or PET-CT criteria\n* Ipsilateral radiological abnormality with benign imaging characteristics and technically amenable to both thermal ablation and surgery\n* Able and willing to give informed consent\n* Randomisation approved by MDT\n\nExclusion criteria (any of):\n\n* Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast\n* Contraindication or unwillingness for either surgery or thermal ablation\n* Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks\n* Unwilling to undergo either LA or thermal ablation\n* Unwilling to comply with study visit schedule\n* Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only)\n* Life-limiting comorbidity (at the discretion of the PI)\n* Clinical and\u002For biochemical evidence of autonomous cortisol secretion sufficient, in the opinion of the patient's physician, to mandate a unilateral adrenalectomy independent of autonomous aldosterone secretion","ALL","18 Years",{"count":134,"type":135},122,"ESTIMATED","INTERVENTIONAL",[138],"NA","The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria.\n\nSecondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought.\n\n* Frequency and severity of adverse events\n* Length of inpatient stay\n* Patient satisfaction\n* Quality of life\n* Return to activities of daily living\n\nAn additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.",[141],"Primary Aldosteronism",[143,144,145,146],"Thermal","Ablation","Laparoscopic","Adrenalectomy","2026-02-19",{"date":149,"type":150},"2026-02-23","ACTUAL",{"date":152,"type":150},"2022-09-01",{"date":154,"type":135},"2026-09-01",{"name":5,"class":6},6]