[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475336":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":27,"responsibleParty":44,"collaborators":47,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":7,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":7,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Austin Health","OTHER_GOV",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"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).",[14],{"name":15,"affiliation":16,"role":17},"Peter De Cruz, MBBS PhD FRACP","Austin Health, Melbourne","PRINCIPAL_INVESTIGATOR",[19,23],{"name":15,"role":20,"phone":21,"phoneExt":7,"email":22},"CONTACT","+61 3 9496 6233","Peter.DeCruz@austin.org.au",{"name":24,"role":20,"phone":25,"phoneExt":7,"email":26},"Raquel Pena, B.Pharm, CTC","+61 3 9496 5327","IBDtrials@austin.org.au",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Melbourne","Victoria","3084","Australia","AU",{"type":36,"coordinates":37},"Point",[38,39],144.96332,-37.814,{"lat":39,"lon":38},[42],{"name":24,"role":20,"phone":43,"phoneExt":7,"email":26},"+613 9496 5327",{"type":17,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Dr Peter De Cruz","Head of Inflammatory Bowel Disease Unit",[48,51,54,56],{"name":49,"class":50},"Florey Institute of Neuroscience and Mental Health","UNKNOWN",{"name":52,"class":53},"University of Melbourne","OTHER",{"name":55,"class":53},"The Bionics Institute of Australia",{"name":57,"class":50},"University of Queensland Diamantina Institute","100475336","the-electrx-study---a-neurotechnology-approach-to-the-treatment-of-ibd-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":68,"type":69},13,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.",[75],"Crohn Disease",[77,78],"Resectional surgery","Post operative prevention of Crohn's recurrence","2023-02-06",{"date":81,"type":82},"2023-02-08","ACTUAL",{"date":84,"type":82},"2022-07-08",{"date":86,"type":69},"2028-07",{"name":5,"class":6},1]