[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prove pharm\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":80},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100550520","phase-3-indigotindisulfonate-sodium-injection-usp-as-an-aid-in-the-determination-of-ureteral-patency-in-pediatric-patients-100550520",false,"NCT06448143","Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients","An Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics and Conspicuity of Bludigo® When Used as an Aid in the Determination of Ureteral Patency in Pediatric Patients","Inclusion Criteria:\n\nI01. Patients from birth to \\\u003C 17 years\n\nI02. Patients whose Parents or Legal Authorized Representative (LAR) have signed a written, IRB approved, informed consent form (ICF) and applicable assent obtained.\n\nI03. Patients scheduled for urological or gynecological surgical procedures in which the patency of the ureters must be assessed by the surgeon during the surgery.\n\nExclusion Criteria:\n\nE01. For patients ≥ 1 year of age, Stage 5 Chronic Kidney Failure (defined as an eGFR (estimated glomerular filtration rate) ≤ 15mL\u002Fmin\u002F1.73 m2). (Calculated using the revised \"Bedside Schwartz\" equation (Schwartz et al. 2009) ). The revised \"Bedside Schwartz\" for eGFR is calculated as follows. eGFR (mL\u002Fmin\u002F1.73m2) = 0.413 \\* height\u002FScr, where height is baseline height measured in cm and Scr is baseline serum creatine measured in mg\u002FdL;\n\nFor patients less than 1 year of age, measured serum creatinine greater than 1.5-times the upper limit of normal (\\>97.5 percentile) based on the reference table in Boer et al., 2010.\n\nE02. Patients weighing less than 5 kgs.\n\nE03. Patients with known severe hypersensitivity reactions to Bludigo® or other dyes including contrast agents.\n\nE04. Patients with a history of, or being evaluated or treated for, gynecologic, renal, or urogenital (ureteral or bladder) cancer.\n\nE05. Patients with known congenital cardiac conditions or who have a history of arrythmia, hypotension, hypertension, bradycardia or tachycardia.\n\nE06. Patients, as assessed by the Investigator, with other conditions \u002F concomitant diseases precluding their safe participation in this study (e.g., major systemic diseases).\n\nE07. Unable to meet specific protocol requirements (e.g., scheduled visits), or has a condition that could lead to non-compliance with the study procedures or patient\u002Fparent\u002FLAR uncooperative.\n\nE08. Patient is the child of Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.\n\nE09. Patients with a life expectancy ≤ 6 months.\n\nE10. Requirement for concomitant treatment with renal tubule transport inhibitors or with any treatment that could potentially discolor urine (see section 6.6)\n\nE11. Patients who are pregnant or breast feeding.","ALL","17 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is an open-label, multicenter study to evaluate the safety, pharmacokinetics, and conspicuity of a weight-based Bludigo® dose (0.05 mL\u002Fkg rounded up (if necessary) to a minimum of 0.5 mL and not to exceed 2.5 mL) when used as an aid in the determination of ureteral patency in pediatric patients.\n\nThe study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States.\n\nPatients scheduled for urological or gynecological surgical procedures who are \\\u003C 17 years will be screened for participation.\n\nA minimum of 6 patients will be enrolled in each of the following three age groups: birth to \\\u003C6-years old, 6 to \\\u003C 12 years old, 12 to \\\u003C 17 years old.\n\nScreening will occur within 30 days before study drug administration (Day of Surgery).\n\nAfter signing the informed consent, review of inclusion and exclusion criteria will be performed. The collection of medical history and concomitant medications, the completion of a physical examination including vital signs measurement, ECG, and the collection of baseline laboratory testing (samples must be collected within 14 days of day 1) will be completed during the screening period.\n\nOn the Day of Surgery (Day 1) patients will be evaluated for eligibility for treatment.\n\nTo evaluate the efficacy outcomes, each patient will be injected with a weight-based dose of Bludigo® (0.05 mL\u002Fkg rounded up (if necessary) to a minimum of 0.5 mL) the maximum dose to be injected is not to exceed 2.5 mL. The ureteral orifices \u002F urine jet will be observed, and a video will be recorded for 10 minutes. The time that will be captured on video is from the time of Bludigo® injection to 10 minutes post injection. If both ureters cannot be visualized simultaneously, then alternating 15-30 second images of each ureter or ureteral orifice will be obtained. The surgeon should note the time blue color is visualized in each ureter jet stream.\n\nBlood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo® injection.\n\nAll treated patients will have a follow-up visit 14 (± 3) days after the procedure. A final telephone call to assess adverse events (AEs) will occur at Day 30 (±2 days).\n\nSafety assessments will include monitoring of vital signs, AEs and laboratory testing post the procedure.",[26],"Ureter Injury","NOT_YET_RECRUITING","2026-01-20",{"date":30,"type":31},"2026-01-22","ACTUAL",{"date":33,"type":20},"2026-01",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"Prove pharm","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100520308","phase-4-indigotindisulfonate-sodium-injection-usp-as-an-aid-in-the-determination-of-ureteral-patency-100520308","NCT06054880","Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency","An Open-Label, Randomized, Multicenter Study to Evaluate the Safety, Efficacy, and Physician Satisfaction of Two Different Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency","Inclusion Criteria:\n\n* Subjects between ≥ 18 and ≤ 85 years old\n* Subjects who signed a written IRB approved, informed consent form\n* Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure\n\nExclusion Criteria:\n\n* Subjects with stage 4 or 5 Chronic Kidney Failure as evidenced by a GFR \\\u003C30 mL\u002Fmin (calculated using the MDRD formula and standardized by using individual's body surface area) or need for dialysis in the near future, or having only 1 kidney\n* Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes\n* Known history of drug or alcohol abuse within 6 months prior to the time of screening visit\n* Subjects, as assessed by the Investigator, with conditions\u002Fconcomitant diseases precluding their safe participation in this study (e.g. major systemic diseases)\n* Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures\n* Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol\n* Subjects with life expectancy \\\u003C 6 months\n* Requirement for concomitant treatment that could bias primary evaluation.\n* Subjects who are pregnant or breast-feeding","18 Years","85 Years",{"count":49,"type":20},116,[51],"PHASE4","This is a randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Bludigo when used as an aid in the determination of ureteral patency.",[26],"RECRUITING",{"date":30,"type":31},{"date":57,"type":31},"2023-10-12",{"date":59,"type":20},"2026-02-28",{"name":37,"class":38},1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":61},"100522635","phase-4-indigotindisulfonate-sodium-as-an-aid-in-determination-of-ureteral-patency-in-patients-with-renal-impairment-100522635","NCT06085183","Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment","An Open-Label, Randomized, Parallel Group Study to Investigate the Influence of Renal Impairment on the Efficacy and Safety of Two Doses of Bludigo™ When Used as an Aid in the Determination of Ureteral Patency","Inclusion Criteria:\n\n* Subjects between ≥ 18 and ≤ 85 years old\n* Subjects who signed a written IRB approved, informed consent form\n* Subjects scheduled for a surgical procedure in which the patency of the ureter must be assessed by cystoscopy following the procedure.\n* An estimated glomerular filtration rate (eGFR) at baseline will be determined using the Modification of Diet in Renal Disease formula (MDRD) and standardized by using individual's body surface area.\n\nSubject's renal function will be defined based on the following criteria:\n\n* Normal subjects: eGFR of ≥90 mL\u002Fmin\n* Mild renal impairment: eGFR 60 to 89 mL\u002Fmin\n* Moderate renal impairment: eGFR 30 to 59 mL\u002Fmin\n* Severe renal impairment: eGFR 15 to 29 mL\u002Fmin\n\nSubjects with normal renal function that are judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the Screening Visit and\u002For prior to administration of study drug.\n\nPatients with renal impairment (mild, moderate, or severe) who have a diagnosis of chronic (\\>6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in renal function) renal insufficiency meeting criteria at the Screening Visit\n\nExclusion Criteria:\n\n* Subjects with eGFR \\\u003C15 mL\u002Fmin or expected need for dialysis in the near future, or having only 1 kidney\n* Subjects with known severe hypersensitivity reactions to Bludigo™ or other dyes, including contrast dyes\n* Known history of drug or alcohol abuse within 6 months prior to the time of screening visit\n* Subjects, as assessed by the Investigator, with conditions\u002Fconcomitant diseases precluding their safe participation in this study (e.g., major systemic diseases)\n* Unable to meet specific protocol requirements (e.g., scheduled visits) or subject is uncooperative or has a condition that could lead to non-compliance with the study procedures\n* Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol\n* Subjects with life expectancy \\\u003C 6 months\n* Requirement for concomitant treatment that could bias primary evaluation.\n* Subjects who are pregnant or breast-feeding",{"count":70,"type":20},48,[51],"This is an open label, randomized, multicenter study to evaluate the efficacy and safety of two dose levels (2.5 mL and 5.0 mL) of Indigotindisulfonate Sodium Injection, USP 0.8% when used as an aid in the determination of ureteral patency in patients with different degrees of renal impairment.",[26],{"date":30,"type":31},{"date":76,"type":31},"2023-12-20",{"date":78,"type":20},"2026-07-31",{"name":37,"class":38},""]