[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520308":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":48,"responsibleParty":66,"collaborators":37,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":37,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":37,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":37,"overallStatus":51,"whyStopped":37,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Prove pharm","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Saline","PLACEBO_COMPARATOR","116 subjects treated with 5 ml of saline then crossover to treatment arm",[13],"Other: Saline injection 0.9%",{"label":15,"type":16,"description":17,"interventionNames":18},"High Dose","EXPERIMENTAL","58 subjects randomly treated with 5 mL of drug",[19,13],"Drug: Indigotindisulfonate sodium 0.8%",{"label":21,"type":16,"description":22,"interventionNames":23},"Low Dose","58 subjects randomly treated with 2.5 mL of drug",[19,13],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Indigotindisulfonate sodium 0.8%","Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.",[15,21],[31],"Bludigo",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"OTHER","Saline injection 0.9%","Placebo",[15,21,9],null,[39],{"name":40,"affiliation":41,"role":42},"Michelle Boytim, Ph.D.","Provepharm SAS","STUDY_DIRECTOR",[44],{"name":40,"role":45,"phone":46,"phoneExt":37,"email":47},"CONTACT","610-850-7115","michelle.boytim@provepharm.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Albany Medical Center","RECRUITING","Albany","New York","12008","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-73.75623,42.65258,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":37,"phoneExt":37,"email":37},"Mark White, MD",{"type":67,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100520308","phase-4-indigotindisulfonate-sodium-injection-usp-as-an-aid-in-the-determination-of-ureteral-patency-100520308",false,"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","ALL","18 Years","85 Years",{"count":79,"type":80},116,"ESTIMATED","INTERVENTIONAL",[83],"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.",[86],"Ureter Injury","2026-01-20",{"date":89,"type":90},"2026-01-22","ACTUAL",{"date":92,"type":90},"2023-10-12",{"date":94,"type":80},"2026-02-28",{"name":5,"class":6},1]