[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100334793":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":69,"collaborators":32,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":32,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":32,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":32,"overallStatus":49,"whyStopped":32,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group - Ketorlac (NSAID)","ACTIVE_COMPARATOR","Subjects will receive a one-time intravenous injection of 1 ml of Ketorlac 30 mg\u002Fml prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical\u002Fsurgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion\u002Fexclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.",[13],"Drug: Ketorolac Trometamol 30Mg\u002F1mL Injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group - Normal Saline","PLACEBO_COMPARATOR","Subjects in the control group will receive a one-time 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure. After consent and during screening visit demographic information, medical\u002Fsurgical history, and height and weight will be collected. On Day 0 subject will be randomized to NSAID or Saline using inclusion\u002Fexclusion criteria and the procedure data will be collected. On Day 1 subject will receive a follow up phone call and complete AUA Symptom Score, USS Questionnaire 1 and USS Questionnaire 2 and any adverse events will be assessed. These questionnaires will again be administered on the day of stent removal and again 1 to 2 months post stent removal.",[19],"Drug: Normal saline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ketorolac Trometamol 30Mg\u002F1mL Injection","Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg\u002Fml prior to the start of the ureteroscopic procedure.",[9],[27],"Toradol IV\u002FIM",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Normal saline","Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Alana Desai, MD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","(314)","desaia@email.wustl.edu",{"name":43,"role":39,"phone":44,"phoneExt":32,"email":45},"Karla Bergeron, CCRP","(314) 454-7325","bergeronk@email.wustl.edu",[47],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Washington University","RECRUITING","St Louis","Missouri","63110","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-90.19789,38.62727,{"lat":59,"lon":58},[62,65],{"name":63,"role":39,"phone":64,"phoneExt":32,"email":45},"Karla Bergeron","314-454-7325",{"name":66,"role":39,"phone":67,"phoneExt":32,"email":68},"Aleksandra Klim, RN, BSN","(314) 747-9781","klima@wustl.edu",{"type":70,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100334793","early-phase-1-nsaids-stent-study-100334793",false,"NCT03638999","NSAIDs Stent Study","A Prospective, Randomized, Pilot Study of Preoperative Anti-Inflammatory Therapy for Ureteral Stent Symptoms","Inclusion Criteria:\n\n* Over 18 years of age and willing and able to provide informed consent\n* Patients with renal urolithiasis planning to undergo ureteral stent placement following ureteroscopic manipulation\n\nExclusion Criteria:\n\n* Patients requiring a bilateral stone procedure.\n* Patients on a chronic non-steroidal anti-inflammatory drugs (NSAIDs) including Aspirin defined as any NSAIDs use for more than fifteen days within thirty days prior to the procedure. Exception: use of daily Aspirin 81 mg is allowed.\n* Patients on any steroid therapy.\n* Patients with prescription anti-inflammatory drugs.\n* Patients with gastrointestinal ulcers.\n* Patients with ureteral obstruction or stricture unrelated to stone disease.\n* Patients with active urinary tract infection as evidence of untreated positive urine culture obtained prior to the procedure (as part of pre-operative testing).\n* Patients with preexisting indwelling ureteral stent\n* Patients who are pregnant or lactating.\n* Patients with renal or liver impairment.\n* Patients with concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would render the patient inappropriate for enrollment.","ALL","18 Years",{"count":81,"type":82},36,"ESTIMATED","INTERVENTIONAL",[85],"EARLY_PHASE1","This is a pilot study to (1) evaluate the effect of Ketorolac on inflammatory response and its impact on stent related symptoms in patients undergoing stent placement procedure and (2) assess feasibility of recruitment, randomization, assessment procedures and implementation of the study intervention.",[88,89],"Ureteral Stent Placement","Kidney Stone","2025-12-15",{"date":92,"type":93},"2025-12-22","ACTUAL",{"date":95,"type":93},"2018-07-31",{"date":97,"type":82},"2027-10",{"name":5,"class":6},1]