[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100349559":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":140,"collaborators":142,"id":151,"slug":152,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":26,"enrollmentInfo":161,"targetDuration":26,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vacuum","ACTIVE_COMPARATOR","The pleural fluid will be drained by the syringe system with a one-way valve tubing system provided in the kit. Selection of the vacuum pressure will be at the discretion of the proceduralist, as per standard of care. Participants in this arm will undergo Vacuum-Based IPC.",[13],"Procedure: Vacuum-Based IPC",{"label":15,"type":16,"description":17,"interventionNames":18},"Gravity","EXPERIMENTAL","The pleural fluid will be drained using gravity drainage to a bag positioned at bedside. Participants in this arm will undergo Gravity-Based IPC.",[19],"Procedure: Gravity-Based IPC",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Vacuum-Based IPC","An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via suction.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Gravity-Based IPC","An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via gravity.",[15],[32],{"name":33,"affiliation":5,"role":34},"Lonny Yarmus, DO","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"IP Research","CONTACT","410-502-2533","IPresearch@jhmi.edu",[42,63,79,94,109,124],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Northwest Community Healthcare","RECRUITING","Arlington Heights","Illinois","60005","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-87.98063,42.08836,{"lat":54,"lon":53},[57,60],{"name":58,"role":38,"phone":26,"phoneExt":26,"email":59},"Neeraj Desai, MD","desai@chestcenter.com",{"name":61,"role":38,"phone":26,"phoneExt":26,"email":62},"Brittany Adams","badams1@NCH.ORG",{"facility":64,"status":44,"city":65,"state":66,"zip":67,"country":48,"countryCode":49,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":51,"coordinates":69},[70,71],-76.61219,39.29038,{"lat":71,"lon":70},[74,78],{"name":75,"role":38,"phone":76,"phoneExt":26,"email":77},"Lonny Yarmus","410-502-5224","lyarmus@jhmi.edu",{"name":75,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":80,"status":44,"city":81,"state":82,"zip":83,"country":48,"countryCode":49,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":51,"coordinates":85},[86,87],-79.93275,32.77632,{"lat":87,"lon":86},[90],{"name":91,"role":38,"phone":92,"phoneExt":26,"email":93},"Gerard Silvestri, MD","843-792-9200","silvestr@musc.edu",{"facility":95,"status":44,"city":96,"state":97,"zip":98,"country":48,"countryCode":49,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":51,"coordinates":100},[101,102],-86.78444,36.16589,{"lat":102,"lon":101},[105],{"name":106,"role":38,"phone":107,"phoneExt":26,"email":108},"Fabien Maldonado, MD","615-936-8422","fabien.maldonado@vanderbilt.edu",{"facility":110,"status":44,"city":111,"state":112,"zip":113,"country":48,"countryCode":49,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Swedish Medical Center","Seattle","Washington","98104",{"type":51,"coordinates":115},[116,117],-122.33207,47.60621,{"lat":117,"lon":116},[120],{"name":121,"role":38,"phone":122,"phoneExt":26,"email":123},"Christopher R. Gilbert, MD","206-215-6800","Christopher.Gilbert@swedish.org",{"facility":125,"status":126,"city":127,"state":26,"zip":26,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"University of Oxford","NOT_YET_RECRUITING","Oxford","United Kingdom","UK",{"type":51,"coordinates":131},[132,133],-1.25596,51.75222,{"lat":133,"lon":132},[136],{"name":137,"role":38,"phone":138,"phoneExt":26,"email":139},"Najib M Rahman, FRCP DPhil","01865 225205","najib.rahman@ndm.ox.ac.uk",{"type":141,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[143,145,146,147,148,149],{"name":144,"class":6},"Rocket Medical plc",{"name":110,"class":6},{"name":80,"class":6},{"name":125,"class":6},{"name":95,"class":6},{"name":43,"class":150},"UNKNOWN","100349559","gravity-versus-vacuum-based-indwelling-tunneled-pleural-drainage-system-100349559",false,"NCT03831386","Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System","The Impact of a Gravity Versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial","NEWTON","Inclusion Criteria:\n\n* Clinical indications for placement of IPC for malignant pleural effusion\n\n  a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion\n* Clinically confident symptomatic malignant pleural effusion\n\n  1. Histocytological proof of pleural malignancy\n  2. Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space\n* Plans for placement of IPC within ten days of enrollment\n* Age \\> 17 years\n* Sufficient fluid on ultrasound to allow for safe insertion of IPC\n\nExclusion Criteria:\n\n* Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain\n* Pregnant or lactating mothers\n* Previous ipsilateral chemical pleurodesis\n* Current contralateral indwelling pleural catheter\n* Known rib or thoracic skeletal metastasis causing pain\n* Concern for active pleural infection\n* Respiratory failure\n* Irreversible bleeding diathesis\n* Inability to provide care for indwelling tunneled pleural catheter\n* Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit\n* Estimated life expectancy of \\\u003C 30 days (however, active enrollment in hospice program is not an exclusion criteria)\n* Inability to read\u002Funderstand\u002Fwrite in the English language\n* Inability to follow-up for appointments\u002Fprotocol\n* Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the investigator would mean participation in the study would be contraindicated.\n* Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial","ALL","18 Years",{"count":162,"type":163},200,"ESTIMATED","INTERVENTIONAL",[166],"NA","Malignant pleural effusion remains a debilitating complication of end stage cancer, which can be greatly improved by the introduction of the indwelling tunneled pleural catheter (IPC). However, there is no standard of care regarding drainage and limited data on the utility of different drainage techniques. In addition, many patients develop discomfort and chest pain during drainage. The investigators propose to evaluate gravity drainage and suction drainage on quality of life measures and outcomes.",[169],"Pleural Effusion","2025-12-09",{"date":172,"type":173},"2025-12-17","ACTUAL",{"date":175,"type":173},"2019-01-31",{"date":177,"type":163},"2026-12-31",{"name":5,"class":6},6]