[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100463933":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":53,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":20,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of California, Davis","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Port Robotic Surgery Arm","EXPERIMENTAL","Study subjects will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the Intuitive Da Vinci Single Port SP system",[13],"Device: Single port robotic colorectal surgical procedure",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Single port robotic colorectal surgical procedure","After screening and counseling, study subjects who wish to participate will undergo the colorectal surgical procedure (determined based on routine standard clinical care) using the alternate Intuitive Da Vinci Single Port SP system rather than the currently used multiport system, (Intuitive Da Vinci Multiport Xi System).\n\nUsing standardized case report forms, the investigators will track clinical parameters and describe the safety \\& quality event rate for SP platform transabdominal and transanal colorectal operations.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Ankit Sarin, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","9167034472","axsarin@ucdavis.edu",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Pallavi Vaidya, BPharm","9167346609","pmvaidya@ucdavis.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"UC Davis Medical Center","RECRUITING","Sacramento","California","95817","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-121.4944,38.58157,{"lat":47,"lon":46},[50],{"name":23,"role":27,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54,56,58,60],{"name":55,"class":6},"University of California, San Francisco",{"name":57,"class":6},"Yale University",{"name":59,"class":6},"Henry Ford Hospital",{"name":61,"class":6},"University of Massachusetts, Worcester","100463933","evaluation-of-single-port-sp-robotic-technology-in-colorectal-surgery-100463933",false,"NCT05321134","Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery","Inclusion Criteria:\n\n* The subject is male or female, greater than or equal to 18 years of age. If female, the subject has a negative urine pregnancy test and is not lactating, or has not been of childbearing potential for at least 3 months prior to use of study product. To be considered to be not of childbearing potential, the subject must be postmenopausal for at least 2 years; have had a hysterectomy or bilateral tubal ligation, or be proven to be otherwise incapable of pregnancy. If of childbearing potential, the subject must have been practicing one of the following methods of contraception consistently for at least 1 month prior to study entry and agree to continue practicing it during the study: hormonal contraceptives, intrauterine device, spermicide and barrier, spouse\u002Fpartner sterility; or is practicing abstinence and agrees to continue abstinence or to start an acceptable method of contraception from the above list if sexual activity commences.\n* There is documentation of a colorectal diagnosis requiring operative interventions with clinical plans for a robotic operation.\n* For robotic transanal procedures, patients who would meet standard guidelines for a transanal procedures (T1N0 rectal adenocarcinoma, Precancerous adenomas, and localized neuroendocrine tumors) distal to 15 cm from the anal verge.\n* The subject is in good general health as evidenced by medical history and physical examination\n* The subject is able and willing to provide written informed consent.\n* The subject agrees to comply with the requirements of the protocol and complete study measures.\n* The subject has stable residence and telephone.\n\nExclusion Criteria:\n\n* The subject is child less than 18 years of age\n* The subject is a female who is pregnant or lactating\n* The subject falls under the American Society of Anesthesia Class IV (Patients with severe systemic disease that is a constant threat to life).\n* The subject falls under American Society of Anesthesia Class V (Moribund patients who is not expected to survive without the operation)\n* The subject has a history of clinically significant renal, hepatic, neurological, cardiac or chronic pulmonary disease that in the judgment of the investigator precludes participation.\n* The subject has advanced\u002F Stage IV cancer\n* The subject has received neo-adjuvant chemotherapy or radiation therapy\n* The subject requires an emergency operation.\n* The subject is unable to fully comprehend or consent to the study\n* The subject is unwilling to be available for follow-up assessments.","ALL","18 Years",{"count":71,"type":72},25,"ESTIMATED","INTERVENTIONAL",[75],"NA","Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.",[78,79,80,81],"Colo-rectal Cancer","Rectal Prolapse","Colostomy Stoma","Colorectal Disorders",[83,84,85,86],"robotic surgery","colorectal surgery","single port","Intuitive SP platform","2026-05-26",{"date":89,"type":90},"2026-05-29","ACTUAL",{"date":92,"type":90},"2022-04-28",{"date":94,"type":72},"2028-04",{"name":5,"class":6},1]