[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567703":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":31,"responsibleParty":82,"collaborators":24,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":24,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":123,"overallStatus":34,"whyStopped":24,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","Arm 1 includes procedures to be performed robotically that have an adult model or already established preclinical evidence including: Sleeve Gastrectomy, Cholecystectomy, Splenectomy, Hysterectomy, endometriosis, ureteral re-implant, and cervical and thoracic tracheoplasty, thymectomy, lobectomy\u002Fwedge lung resection, lung segmentectomy",[13],"Device: da Vinci Xi Robotic Surgery System",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2","Arm 2 will be performed after all patients in Arm 1 have completed their procedures and where additional preclinical performance testing is required, including: Bronchoplasty, Endoscopic Laryngeal\u002FPharyngeal Suturing, including: Vocal Feminization, Laryngeal Cleft Repair, Endolaryngeal Adjacent Tissue Transfer, Pharyngoplasty; Ileocolonic Resections; Laryngoplasty with or without Graft; Proctectomy with Ileal Pouch-Anal Anastomosis (IPAA)",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","da Vinci Xi Robotic Surgery System","The da Vinci Xi Surgical System is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument and EndoWrist Xi instruments and accessories.\n\nThe surgeon seated at the surgeon console controls all movement of the EndoWrist Xi instruments and Camera Instrument using two master controls and a set of foot pedals. The surgeon views the three-dimensional endoscopic image on a high-resolution stereo viewer (3D viewer), which provides him\u002Fher\u002Fthey a view of patient anatomy and instrumentation, along with icons and other user interface features. The Vision Cart includes the supporting electronic and video processing equipment for the system.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Karthik Balakrishnan, MD, MPH, FAAP, FACS","CONTACT","(650) 724-4800","kbala@stanford.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Lucile Packard Children's Hospital Stanford","RECRUITING","Stanford","California","94305","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-122.16608,37.42411,{"lat":44,"lon":43},[47,51,54,56,58,60,62,64,66,68,70,72,74,76,78,80],{"name":48,"role":28,"phone":49,"phoneExt":24,"email":50},"Grant Wells, MS","65-714-4344","gwells2@stanford.edu",{"name":52,"role":53,"phone":24,"phoneExt":24,"email":24},"Natalie Lui, MD, MAS","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":24,"phoneExt":24,"email":24},"Brian Nuyen, MD",{"name":57,"role":53,"phone":24,"phoneExt":24,"email":24},"Faraz Khan, MD",{"name":59,"role":53,"phone":24,"phoneExt":24,"email":24},"Janey S.A. Pratt, MD",{"name":61,"role":53,"phone":24,"phoneExt":24,"email":24},"Nichole Tyson, MD",{"name":63,"role":53,"phone":24,"phoneExt":24,"email":24},"Stephanie Cizek, MD",{"name":65,"role":53,"phone":24,"phoneExt":24,"email":24},"Douglas Sidell, MD",{"name":67,"role":53,"phone":24,"phoneExt":24,"email":24},"Tulio Valdez, MD, MSc",{"name":69,"role":53,"phone":24,"phoneExt":24,"email":24},"Kara Meister, MD, FAAP, FACS",{"name":71,"role":53,"phone":24,"phoneExt":24,"email":24},"Daniel Han, MD",{"name":73,"role":53,"phone":24,"phoneExt":24,"email":24},"Kunj Sheth, MD",{"name":75,"role":53,"phone":24,"phoneExt":24,"email":24},"Michael Ma, MD",{"name":77,"role":53,"phone":24,"phoneExt":24,"email":24},"Erin Grantham, MD",{"name":79,"role":53,"phone":24,"phoneExt":24,"email":24},"Patrick Kiessling, MD",{"name":81,"role":53,"phone":24,"phoneExt":24,"email":24},"Carolyn Chang, MD",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Karthik Balakrishnan","Professor of Otolaryngology - Head & Neck Surgery","100567703","stanford-program-to-accelerate-robotic-childrens-surgery-100567703",false,"NCT06671639","Stanford Program to Accelerate Robotic Children's Surgery","SPARCS","Inclusion Criteria:\n\n1. Subject is between 6 - 21 years of age (weighing at least 15 kilograms)\n2. Subject clinically diagnosed with a medical condition for which one of the study procedures is appropriate therapy and selected as the treatment of choice by the guardian and surgeon.\n3. Subject without previous treatment using a robotic surgery device\n4. Subject or their guardian is willing and able to provide written informed consent\n5. Subject or their guardian is willing and able to comply with the study protocol requirements\n\nExclusion Criteria:\n\n1. Subject with uncorrected coagulopathy\n2. Subject has clinical requirement for primary open operative procedure\n3. Subject is ASA 4 or 5 status\n4. Subject is contraindicated for general anesthesia or surgery\n5. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent\n6. Subject is pregnant or suspected to be pregnant","ALL","6 Years","21 Years",{"count":97,"type":98},250,"ESTIMATED","INTERVENTIONAL",[101],"NA","The goal of this clinical trial is to provide additional data to confirm safety and performance of the da Vinci Xi Surgical System in a human clinical setting. This pilot study is intended to provide an initial assessment to evaluate the feasibility, safety, and effectiveness for the utilization of the da Vinci Xi on pediatric and adolescent patients. This clinical trial will be conducted under the auspices of Stanford University's IRB approval.",[104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122],"Sleeve Gastrectomy","Cholecystectomy","Splenectomy","Hysterectomy","Endometriosis","Ureteral Re-implant","Cervical and Thoracic Tracheoplasty","Thymectomy","Lobectomy\u002FWedge Lung Resection","Lung Segmentectomy","Bronchoplasty","Endoscopic Laryngeal\u002FPharyngeal Suturing","Vocal Feminization","Laryngeal Cleft Repair","Endolaryngeal Adjacent Tissue Transfer","Pharyngoplasty","Ileocolonic Resections","Laryngoplasty","Proctectomy With Ileal Pouch-Anal Anastomosis",[124,125],"Robotic Surgery","Pediatric Robotic Surgery","2026-04-24",{"date":128,"type":129},"2026-04-30","ACTUAL",{"date":131,"type":129},"2025-08-01",{"date":133,"type":98},"2028-02-28",{"name":5,"class":6},1]