[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100282105":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":47,"collaborators":19,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":19,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":19,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PAMS I","EXPERIMENTAL","During operation, autonomic nerve monitoring will be performed by PAMS I which is composed of two urodynamic systems.",[13],"Device: PAMS I",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","After general anesthesia, pressure sensor of PAMS I is placed into bladder, vagina and rectum. Then pressure change is monitored during performing pelvic autonomic nerve dissection.\n\nBoth PAMS I and IOM will be used for monitoring.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Hee Seung Kim, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","82-2-2072-4863","bboddi0311@gmail.com",[30],{"facility":5,"status":31,"city":32,"state":19,"zip":19,"country":33,"countryCode":19,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Seoul","South Korea",{"type":35,"coordinates":36},"Point",[37,38],126.9784,37.566,{"lat":38,"lon":37},[41,45,46],{"name":42,"role":26,"phone":43,"phoneExt":19,"email":44},"Seungmee Lee, MD","82-2-2072-2821","yumenoarika@naver.com",{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":23,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Hee Seung Kim","Associate Professor","100282105","efficacy-of-pelvic-autonomic-nerve-monitoring-system-pams-i-in-female-patients-with-pelvic-tumors-100282105",false,"NCT02952183","Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors","Exploratory Study for Evaluating the Efficacy of Pelvic Autonomic Nerve Monitoring System (PAMS I) in Female Patients With Pelvic Tumors (FUSION Trial V)","FUSION V","Inclusion Criteria:\n\n* Female, Age ≥ 18 years\n* Patients with pelvic malignant tumor who need surgery.\n\n  * Gynecologic cancer; cervical cancer, uterine cancer, ovarian cancer\n  * Colorectal cancer\n  * Pelvic sarcoma and metastatic pelvic malignant tumor\n* Patients who signed an approved informed consent.\n\nExclusion Criteria:\n\n* Female, Age \\\u003C 18 years\n* Patients with pelvic malignant tumor, but surgery is not indicated.\n* Patients who refused to sign informed consent","FEMALE","18 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"NA","Although nerve-sparing surgery has been introduced for female patients with the pelvic tumors, its success rate depends on operators. To achieve consistency of surgical procedure, It is necessary to adopt pelvic autonomic nerve monitoring technique.\n\nThe Aims of this study is\n\n1. Development of pelvic autonomic nerve monitoring system (PAMS I) by using urodynamic system.\n2. Evaluation of autonomic nerve sparing by intraoperative monitoring with PAMS I\n3. Evaluating the efficacy of PAMS I by intraoperative neurophysiological monitoring (IOM)",[68,69,70],"Cervical Cancer","Uterine Cancer","Ovarian Cancer",[72,73],"Autonomic nerve monitoring","Nerve-sparing surgery","UNKNOWN","2016-10-30",{"date":77,"type":62},"2016-11-02",{"date":79,"type":19},"2015-07",{"name":5,"class":6},1]