[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epiploic-appendagitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epiploic-appendagitis":30},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100637870","diagnosis-of-abdominal-pain-using-rna-levels-the-natural-study-100637870",false,"NCT07579312","Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study","Neutrophil Activation Test Using RNA Levels to Assist in the Diagnosis of Abdominal Pain: The NATURAL Study","NATURAL","Inclusion Criteria:\n\nAge \\> 7 yr old Abdominal pain of likely non-traumatic origin Risk of intra-abdominal infection (see IAI signs) Ability to provide informed consent\u002Fassent Potential to order abdominal CT, ultrasound, endoscopy, or surgery for possible IAI\n\nExclusion Criteria:\n\nAny situation where delay could be detrimental Hemodynamically unstable (see age-adjusted criteria) Prisoner or other involuntary detainee Inability to provide informed consent\u002Fassent",true,"ALL","7 Years",{"count":21,"type":22},1000,"ESTIMATED","OBSERVATIONAL","The NATURAL Study is a prospective, observational, pragmatic study of RNA biomarkers of infections to aid in the diagnosis of abdominal pain.\n\nSummary of Research Study:\n\nHypothesis: A genomic-derived panel of 6 RNA biomarkers present in stabilized whole blood will provide diagnostic information about the presence of bacterial, biofilm, and viral infections in the abdomen. We hypothesize that biomarkers will be more than 90% sensitive with a high (\\>90%) negative predictive value for IAI.\n\nResearch Design: The project design is a prospective, pragmatic, observational study. The NATURAL Study will be sponsored by True Bearing Diagnostics, Inc., and performed at 5 or more academic medical centers. Patients with suspected intra-abdominal infections (IAIs), such as appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess are candidates for this study. This is a broad category of patients that are defined by the suspicion of an internal abdominal infection, usually involving some type of advanced imaging analysis, such as CT scan or ultrasound. All participants will be consented for this observational, minimal-risk study prior to venipuncture. Ultimately, The NATURAL Study will determine the positive agreement (\\~sensitivity) and negative agreement (\\~specificity) of the TruNAV RNA biomarkers in relation to the clinical diagnosis of the presence or absence of an IAI, based on CT scans and\u002For surgical confirmation, the current standard of care for diagnosis of IAI.\n\nObjective: To validate a novel RNA fingerprint in ED patients with suspected IAIs.\n\nThe NATURAL Study is designed to determine the accuracy of novel RNA biomarkers for diagnosis of IAI in patients suspected of having IAI. Subgroup analysis will analyse RNA biomarker for multiple types of actual and suspected IAIs (appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess.)\n\nSubjects: Approximately 1,000 ED patients presenting with abdominal pain that are candidates to receive CT or other confirmatory diagnostics will be enrolled.",[26,27,28,29,30],"Intra Abdominal Infections","Appendicitis Acute","Pyelonephritis","Diverticulitis","Epiploic Appendagitis",[26,32,33,28,29,34,35],"Biomarkers","Appendicitis","Epiploic appendagitis","Gastroenteritis","RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-12","ACTUAL",{"date":42,"type":40},"2026-04-17",{"date":44,"type":22},"2027-09",{"name":46,"class":47},"True Bearing Diagnostics, Inc.","INDUSTRY"]