[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604083":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":64,"collaborators":25,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":93,"overallStatus":99,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: ICG-Assisted Ureteral Identification (Unilateral)","EXPERIMENTAL","Participants assigned to this study will undergo intraoperative ureteral identification using indocyanine green (ICG) fluorescence imaging in either left or right side. A temporary ureteral stent will be inserted on the randomized side (left or right) prior to ureterolysis and endometriosis resection. ICG will be administered through the stent to facilitate real-time fluorescence visualization of the ureter during robot-assisted single-site surgery. The contralateral side will serve as the control arm (standard visualization without ICG).",[13],"Drug: Indocyanine Green (ICG)-Assisted Ureteral Identification",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm B: Standard Visualization (Contralateral Control)","ACTIVE_COMPARATOR",[18],"Procedure: Standard Ureteral Identification without ICG",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Indocyanine Green (ICG)-Assisted Ureteral Identification","A temporary ureteral stent will be placed unilaterally (left or right) prior to robotic procedures in participants undergoing robot-assisted single-site surgery for advanced-stage endometriosis. Indocyanine green (ICG) will be administered through the stent to enable real-time fluorescence imaging for intraoperative ureter identification. The contralateral ureter will be identified using standard visualization techniques without ICG. Side allocation (ICG vs. control) will be determined by computer-generated block randomization.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Standard Ureteral Identification without ICG","Ureter identification will be performed using standard intraoperative visualization techniques without the use of indocyanine green (ICG) fluorescence imaging. This will be done on the contralateral side to the randomized ICG-assisted ureteral identification during robot-assisted single-site surgery for advanced-stage endometriosis.",[15],[32],{"name":33,"affiliation":34,"role":35},"Xiaoming Guan, PhD, MD","Department Chair of Minimally Invasive Gynecologic Surgery","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Ann Tims","CONTACT","8328267464","atims@bcm.edu",[43],{"facility":44,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Texas Childrens Hospital Pavilion for Women","Houston","Texas","77030","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-95.36327,29.76328,{"lat":54,"lon":53},[57,60,61],{"name":33,"role":39,"phone":58,"phoneExt":25,"email":59},"973-330-2602","guanxiaoming@yahoo.com",{"name":33,"role":35,"phone":25,"phoneExt":25,"email":25},{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Qiannan Yang, PhD, MD","SUB_INVESTIGATOR",{"type":35,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"XIAOMING GUAN","Division Chief of Minimally Invasive Gynecologic Surgery","100604083","phase-4-assessing-the-efficacy-of-indocyanine-green-for-ureter-identification-during-robot-assisted-surgery-in-advanced-stage-endometriosis-100604083",false,"NCT07144904","Assessing the Efficacy of Indocyanine Green for Ureter Identification During Robot-Assisted Surgery in Advanced-Stage Endometriosis","A Side-Randomized, Self-Controlled Trial Assessing the Efficacy of Indocyanine Green Fluorescence Imaging for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis","Inclusion Criteria:\n\n* Stage III or IV endometriosis (rASRM classification)\n* Planned robotic transabdominal endometriosis excision with or without hysterectomy.\n\nExclusion Criteria:\n\n\\- Subjects who are part of a vulnerable population will be excluded including those who are prisoners, younger than 18 years old, pregnant, individuals with mental disabilities or cognitive impairment.","FEMALE","18 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The goal of this side-randomized, self-controlled trial, 1-site study is to explore the efficacy of Indocyanine Green Fluorescence (ICG) for Intraoperative Ureter Identification During Robot-Assisted Single-Site Surgery in Advanced-Stage Endometriosis.\n\nResearchers will perform temporary ureteral stent using indocyanine green fluorescence for intraoperative ureteral identification on either the left or right side of subjects who are undergoing a robotic assisted transumbilical resection of advanced endometriosis.\n\nParticipants will be randomized to receive ICG-assisted ureteral identification on either the left or right side. Randomization will be conducted using a computer-generated block randomization method.\n\nThe primary aim is to determine whether ICG-assisted ureter visualization can reduce operative time for endometriosis resection and ureterolysis, and minimize the risk of ureteral injury.\n\nSecondary objectives are to assess the feasibility and safety of temporary ureteral ICG stenting for intraoperative ureter identification in advanced endometriosis.",[84,85,86,87,88,89,90,91,92],"Indocyanine Green (ICG)","Robotic Surgical Procedure","Deep Infiltrating Endometriosis (DIE)","Endometriosis Pelvic","Endometriosis (Diagnosis)","Endometriosis of the Cul-de-sac","Ureteral Stent Placement","Ureteral Injury","Endometriosis Ovaries",[94,95,96,97,98],"ureteral stent placement","indocyanine green","endometriosis","robotic surgery","ureteral identification","NOT_YET_RECRUITING","2025-08-20",{"date":102,"type":103},"2025-08-28","ACTUAL",{"date":105,"type":78},"2025-10-01",{"date":107,"type":78},"2026-03-15",{"name":5,"class":6},1]