[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622597":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":25,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"West Virginia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Xpan Trocar System","ACTIVE_COMPARATOR","Participants will undergo laparoscopic surgery using the Xpan Trocar System. Standard insertion technique will be used to create a 3 mm punch into an already gas-extended abdomen. A total of 3-5 trocars will be placed based on the type of surgery. Once placed, trocars will be radially dilated to the size necessary for the procedure, generally 2 trocars expanded to 5 mm and 2 trocars expanded to 12 mm. Final trocar size will range from 3 mm to 12 mm. Both placement and final dilated size will be documented.",[13],"Device: Xpan Trocar System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care (Non-expanding Trocar)","PLACEBO_COMPARATOR","Participants will undergo laparoscopic surgery using a non-expanding trocar, which is considered the institutions standard of care for the procedure. Trocar size is selected based on surgical requirements and remain fixed throughout the procedure.",[19],"Device: Standard of Care (Non-expanding Trocar)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","A radially dilating trocar system intended to reduce incision trauma by gradually dilating tissue rather than cutting. Allows initial placement at 3 mm and expansion up to 12 mm as needed for surgical access.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"A surgical access device used during laparoscopic procedures that does not expand the incision site and is routinely used in standard practice.",[15],[30],{"name":31,"affiliation":5,"role":32},"Lawrence Tabone, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","304-293-1728","letabone@hsc.wvu.edu",[39],{"facility":5,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Morgantown","West Virginia","26505","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-79.9559,39.62953,{"lat":49,"lon":48},[52,54],{"name":31,"role":35,"phone":53,"phoneExt":25,"email":37},"304-293-3223",{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lawrence Tabone","Associate Professor and Chief of Division of General Surgery","100622597","xpan-non-inferiority-study-100622597",false,"NCT07385690","Xpan Non-Inferiority Study","Inclusion Criteria:\n\n* Individuals scheduled for the following procedures:\n\n  * Sleeve Gastrectomy\n  * Bypass\n  * Revision \\& other bariatric procedures\n  * Robotic procedures\n  * Bariatric patients\n\nExclusion Criteria:\n\n* Any individual not scheduled for the above procedure and\u002For does not meet the age requirments.","ALL","18 Years","89 Years",{"count":68,"type":69},35,"ESTIMATED","INTERVENTIONAL",[72],"NA","A trocar is a surgical instrument with a sharp point and tube and is used to create endoscopic access in the abdomen or chest where endoscopic instruments can be entered \\& used in minimally invasive surgical procedures. Xpan has created an FDA Cleared radially dilating trocar (RDT) that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery. The purpose of this research protocol is to demonstrate that a new FDA Cleared Xpan® radially dilating trocar (RDT) system is at least, just as effective as the existing RDT trocar systems. The procedure will be performed using a radially dilating trocar that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery.",[75],"Bariatric Surgery Candidate","NOT_YET_RECRUITING","2026-02-02",{"date":79,"type":80},"2026-02-04","ACTUAL",{"date":82,"type":69},"2026-02",{"date":84,"type":69},"2027-02",{"name":5,"class":6},1]