[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475336":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":25,"interventions":32,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":68,"collaborators":71,"id":82,"slug":25,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":25,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Austin Health","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and efficacy based on endoscopic recurrence","Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis)","6 months post-operation",[14,17,21],{"measure":15,"description":11,"timeFrame":16},"Endoscopic recurrence","18 months post-operation",{"measure":18,"description":19,"timeFrame":20},"Clinical recurrence","Defined as recurrence of symptoms consistent with recurrent disease, necessitating new treatment, or Crohn's Disease Activity Index (CDAI) \\> 150","6 months and 18 months post-operation",{"measure":22,"description":23,"timeFrame":24},"Surgical recurrence","Defined as the need for further intestinal surgery due to Crohn's disease","6 and 18 months post-operation",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","PREVENTION",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33],{"type":34,"name":35,"description":36,"armGroupLabels":25,"otherNames":25},"DEVICE","Vagus Nerve Stimulator","The device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating\u002Frecording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control\u002FReview Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on\u002Foff the system and perform limited adjustment of the stimulation strategy).",[38],{"name":39,"affiliation":40,"role":41},"Peter De Cruz, MBBS PhD FRACP","Austin Health, Melbourne","PRINCIPAL_INVESTIGATOR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":25,"email":46},"CONTACT","+61 3 9496 6233","Peter.DeCruz@austin.org.au",{"name":48,"role":44,"phone":49,"phoneExt":25,"email":50},"Raquel Pena, B.Pharm, CTC","+61 3 9496 5327","IBDtrials@austin.org.au",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Melbourne","Victoria","3084","Australia","AU",{"type":60,"coordinates":61},"Point",[62,63],144.96332,-37.814,{"lat":63,"lon":62},[66],{"name":48,"role":44,"phone":67,"phoneExt":25,"email":50},"+613 9496 5327",{"type":41,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr Peter De Cruz","Head of Inflammatory Bowel Disease Unit",[72,75,78,80],{"name":73,"class":74},"Florey Institute of Neuroscience and Mental Health","UNKNOWN",{"name":76,"class":77},"University of Melbourne","OTHER",{"name":79,"class":77},"The Bionics Institute of Australia",{"name":81,"class":74},"University of Queensland Diamantina Institute","100475336",false,"NCT05469607","The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD","Inclusion Criteria:\n\n* All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality.\n* Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining bowel.\n* Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine.\n* Patients must have proven history of Crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria).\n\nExclusion Criteria:\n\n* Patients with anastomosis which is endoscopically inaccessible by standard colonoscopy.\n* Patients in whom there is persisting macroscopic abnormality post-surgical resection.\n* Patients with Crohn's disease who have an end stoma (ileostomy or colostomy).\n* Patients for whom endoscopy is not suitable due to co-morbidities or unwell clinical state\n* Inability to give informed consent.\n* Inability to obtain access to the anastomosis at colonoscopy.\n* Suspected perforation of the gastrointestinal tract.\n* Patients who are pregnant or breastfeeding.","ALL","18 Years","80 Years",{"count":91,"type":92},13,"ESTIMATED","INTERVENTIONAL",[27],"The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.",[97],"Crohn Disease",[99,100],"Resectional surgery","Post operative prevention of Crohn's recurrence","2023-02-06",{"date":103,"type":104},"2023-02-08","ACTUAL",{"date":106,"type":104},"2022-07-08",{"date":108,"type":92},"2028-07",{"name":5,"class":6},1]