[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619549":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":20,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":20,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":20},{"fullName":5,"class":6},"Intuitive Surgical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IS-001 Injection","OTHER","Ureter visualization and delineation will be compared between white light (standard of care) and near-infrared (NIR) imaging mode after each of the two single intravenous injections of IS-001.",[13],"Drug: filricianine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","filricianine","IV injection of IS-001 filricianine with near infrared (NIR) imaging",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Clinical Project Manager","CONTACT","4085232100","info.is-001@intusurg.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100619549","phase-3-is-001-injection-in-patients-undergoing-robotic-assisted-colorectal-surgery-100619549",false,"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.","ALL","16 Years","75 Years",{"count":40,"type":41},146,"ESTIMATED","INTERVENTIONAL",[44],"PHASE3","This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation",[47],"Ureter Injury","NOT_YET_RECRUITING","2026-01-14",{"date":51,"type":52},"2026-01-16","ACTUAL",{"date":54,"type":41},"2026-03-31",{"date":56,"type":41},"2027-08-31",{"name":5,"class":6}]