[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ureter-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ureter-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,67,87,105,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100599093","phase-1-evaluation-of-lumitrace-for-visualizing-ureters-during-abdominopelvic-surgeries-100599093",false,"NCT07080008","Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries","A Single Center, Open Label Pilot Study to Assess the Feasibility and Safety of Lumitrace Injection for Intraoperative Ureter Visualization Comparing White Light (WL) Fluorescence (BLUE) in Participants Undergoing Minimally Invasive Abdominopelvic Surgeries","Inclusion Criteria:\n\n1. Age \\> 18 years - male or female\n\n   1. Eligible female non-pregnant subjects who are either not of child-bearing potential or willing to use adequate contraception during the trial\n   2. Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration\n   3. For women of child-bearing potential, the subject should have a negative serum pregnancy test on day of surgery, and agrees to one of the following acceptable contraceptive methods used consistently and correctly from the time of consent through 30 days after Lumitrace administration; i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system, or male partner sterilization\n   4. Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace\n2. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol\n3. Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification\n4. eGFR≥60 mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n1. Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability to complete study requirements or may put the subject at increased risk, or compromise the interpretability of study results, which makes the participant unsuitable for study participation\n2. Participant is anticipated to require ureteral stenting during surgery\n3. Participant has an active urinary tract infection requiring antibiotic therapy\n4. Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance\n5. Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI\n6. Participant with body weight \\\u003C 30 kilogram (kg)\n7. History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered a drug allergy)\n8. Participant has received any investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening\n9. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2\n10. Participants with positive serum pregnancy test",true,"ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.\n\nThe main questions it aims to answer are:\n\n* To evaluate the feasibility and clinical utility of Lumitrace to provide ureter visualization when used in tandem with the KARL STORZ POWER LED BLUE System during laparoscopic abdominopelvic surgery\n* To evaluate the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing laparoscopic abdominopelvic surgery\n\nParticipants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.\n\nUp to 10 participants will be enrolled and will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.\n\nA safety follow-up visit will occur within 14 ±7 days of Lumitrace administration.",[27],"Ureter Injury",[29,30],"Relmapirazin","Lumitrace","RECRUITING","2026-03-31",{"date":34,"type":35},"2026-04-01","ACTUAL",{"date":37,"type":35},"2026-01-30",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"MediBeacon","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":4},"100550520","phase-3-indigotindisulfonate-sodium-injection-usp-as-an-aid-in-the-determination-of-ureteral-patency-in-pediatric-patients-100550520","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.","17 Years",{"count":53,"type":21},18,[55],"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.",[27],"NOT_YET_RECRUITING","2026-01-20",{"date":61,"type":35},"2026-01-22",{"date":63,"type":21},"2026-01",{"date":39,"type":21},{"name":66,"class":42},"Prove pharm",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":43},"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","85 Years",{"count":76,"type":21},116,[78],"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.",[27],{"date":61,"type":35},{"date":83,"type":35},"2023-10-12",{"date":85,"type":21},"2026-02-28",{"name":66,"class":42},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"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":95,"type":21},48,[78],"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.",[27],{"date":61,"type":35},{"date":101,"type":35},"2023-12-20",{"date":103,"type":21},"2026-07-31",{"name":66,"class":42},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100619549","phase-3-is-001-injection-in-patients-undergoing-robotic-assisted-colorectal-surgery-100619549","NCT07346066","IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery","A Phase 3 Multi-Center Efficacy Study of Filricianine Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery Using the da Vinci Surgical System With Firefly® Fluorescence Imaging","Inclusion Criteria:\n\n1. Male and female participants between the ages of 16 and 75, inclusive\n2. Participant is scheduled to undergo robotic-assisted colectomy using the da Vinci X\u002FXi Surgical System with SFF Fluorescence Imaging Exclusion Criteria\n\n1\\. Participant is pregnant or nursing 2. Participant has known current acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Participant has any of the following screening laboratory values: eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n\n1. Aspartate aminotransferase (AST) ≥ 2.5 × ULN\n2. Alanine aminotransferase (ALT) ≥ 2.5 × ULN\n3. Total Bilirubin \\> 2mg\u002FdL 4. Participant has any concomitant non-colorectal cancer 5. Participant has any circumstances that, in the judgment of the Investigator, might make them not a suitable candidate for the study 6. Participants have already been enrolled in another investigational drug or device study within the past 6 months 7. Participants with known or suspected hypersensitivity to indocyanine green (ICG) or any components of the formulation used 8. Participant is expected to receive or has received other methods for ureter identification during the surgery (e.g., ureteral stent placement, illuminated catheters, retrograde ICG injections) before the administration of IS-001 9. The duration of the surgery is expected to be less than 90 minutes as determined during preoperative planning.","16 Years","75 Years",{"count":115,"type":21},146,[55],"This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation",[27],"2026-01-14",{"date":121,"type":35},"2026-01-16",{"date":32,"type":21},{"date":124,"type":21},"2027-08-31",{"name":126,"class":42},"Intuitive Surgical",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":43},"100592002","comparing-different-diameter-furss-with-similar-resds-for-the-treatment-of-upper-urinary-tract-stones-100592002","NCT06987760","Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones","Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials","Inclusion Criteria:\n\n\\- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.\n\n2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.\n\n  2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.\n\n  6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.\n\n  8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.","80 Years",{"count":136,"type":21},206,[138],"NA","Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.",[27,141,142],"Urolithiasis; Lower Urinary Tract","Efficacy, Self",[144,145,146],"Urolithiasis","Ratio of Endoscope-Sheath Diameter","Flexible ureteroscope","2025-05-22",{"date":149,"type":35},"2025-05-23",{"date":151,"type":35},"2025-03-19",{"date":153,"type":21},"2026-12-30",{"name":155,"class":156},"Ningbo No. 1 Hospital","OTHER"]