[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CoapTech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":49},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Gastrostomy","Gastrostomy Complications","Pediatric Disorder","Ultrasound",[27,32,33,34,30,35],"Pediatric Gastrostomy","Device Feasibility","Device Safety","POCUS","RECRUITING","2026-07-30",{"date":39,"type":40},"2026-07-31","ACTUAL",{"date":42,"type":40},"2023-07-07",{"date":44,"type":21},"2028-12-31",{"name":46,"class":47},"CoapTech","INDUSTRY",3,""]