[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513503":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":29,"locations":39,"responsibleParty":88,"collaborators":90,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":18,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":18,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"CoapTech","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Percutaneous Ultrasound Gastrostomy (PUG)","EXPERIMENTAL","Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist",[13],"Device: Percutaneous Ultrasound Gastrostomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Percutaneous Radiologic Gastrostomy","NO_INTERVENTION","A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Percutaneous Ultrasound Gastrostomy","Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System",[9],[26,27,28],"Ultrasound Gastrostomy","PUG","PUMA-G Pediatric Procedure",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Jack Kent, MPH","CONTACT","4102151638","jack@coaptech.com",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Steven Tropello, MD","4348255184","steven@coaptech.com",[40,59,73],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Children's National Hospital","RECRUITING","Washington D.C.","District of Columbia","20010","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-77.03637,38.89511,{"lat":52,"lon":51},[55],{"name":56,"role":32,"phone":57,"phoneExt":18,"email":58},"Bhupender Yadav, MD","202-476-4252","byadav@childrensnational.org",{"facility":60,"status":42,"city":61,"state":61,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Nyph\u002FCumc","New York","10019",{"type":49,"coordinates":64},[65,66],-74.00597,40.71427,{"lat":66,"lon":65},[69],{"name":70,"role":32,"phone":71,"phoneExt":18,"email":72},"Joshua Weintraub, MD","212-326-8874","jw750@cumc.columbia.edu",{"facility":74,"status":42,"city":75,"state":76,"zip":77,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Children's Hospital Of Phildelphia","Philadelphia","Pennsylvania","19104",{"type":49,"coordinates":79},[80,81],-75.16362,39.95238,{"lat":81,"lon":80},[84],{"name":85,"role":32,"phone":86,"phoneExt":18,"email":87},"Anne Marie Cahill, MD","267-425-7118","CAHILL@chop.edu",{"type":89,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[91,94,96],{"name":92,"class":93},"Children's Hospital of Philadelphia","OTHER",{"name":95,"class":93},"Columbia University",{"name":97,"class":93},"Children's National Research Institute","100513503","pediatric-percutaneous-ultrasound-gastrostomy-technique-100513503",false,"NCT05966311","Pediatric Percutaneous Ultrasound Gastrostomy Technique","A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy","Inclusion Criteria:\n\n* Informed consent must be obtained from the patient or a Legally Authorized Representative (ex. parent\u002Fguardian) before any study-specific assessment is performed\n* Weight ≥5 (Phase 0, Phase 1, Phase 2)\n* Weight ≥3kg and \\\u003C10kg (Phase 3)\n* Estimated abdominal wall thickness ≤3cm\n* Indication for gastrostomy tube placement, with or without jejunal access tubing via gastrostomy tract, determined to be present for any of the following reasons:\n* Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate)\n* Neurologic: Head trauma, Cerebral palsy\n* Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel disease, malabsorption\n* Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food refusal\n* Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical care team\n* Anticipated discharge \\> 24 hrs following gastrostomy\n\nExclusion Criteria:\n\n* Temperature ≥ 38 C\n* Systolic BP \\\u003C 80 or \\> 180 mmHg\n* Heart Rate \\\u003C 50 or \\> 160\n* Estimated abdominal wall thickness \\>3cm\n* Coagulopathy defined by INR \\> 1.7 or Platelets \\\u003C50,000\n* Presence of a contraindication to being in proximity to a magnet (e.g. implantable metallic device).\n* History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma or upper-abdominal surgery.\n* Scoliosis\n* Atypical organ placement including microgastria\n* Involvement in other investigational trials within 30 days prior to screening,\n* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test\n* Patients with HgB \\\u003C 7g\u002FdL, or fluid resuscitated within 48hrs prior, or received blood transfusion within 48hrs prior, or active life threatening GI bleeding\n* Esophageal Diseases: Atresia, stricture, caustic ingestion\n* Spinal anomalies or atypical organ placement\n* Any other medical condition(s) that may put the patient at risk or influence study results in the investigator's opinion, based on the performance of a pre-procedural assessment.","ALL","0 Years","21 Years",{"count":109,"type":110},80,"ESTIMATED","INTERVENTIONAL",[113],"NA","The purpose of this research study is to test a new device called the PUMA-G Pediatric System. The research will measure if the device works well to safely aid doctors placing gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational device that uses ultrasound and magnets to guide insertion of a feeding tube.",[116,117,118,119],"Gastrostomy","Gastrostomy Complications","Pediatric Disorder","Ultrasound",[116,121,122,123,119,124],"Pediatric Gastrostomy","Device Feasibility","Device Safety","POCUS","2026-07-30",{"date":127,"type":128},"2026-07-31","ACTUAL",{"date":130,"type":128},"2023-07-07",{"date":132,"type":110},"2028-12-31",{"name":5,"class":6},3]