[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644558":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":34,"responsibleParty":62,"collaborators":12,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":12,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":12,"enrollmentInfo":73,"targetDuration":12,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":85,"whyStopped":12,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Duke University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Arm","NO_INTERVENTION","In the control arm, surgeons will perform two microsurgical anastomoses without the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the control arm, only the first microsurgical anastomosis for each bilateral DIEP flap reconstruction will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) perforators and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"ORASIS Arm","EXPERIMENTAL","In the ORASIS arm, surgeons will perform two microsurgical anastomoses with the use of ORASIS in either bilateral or unilateral Deep Inferior Epigastric Perforator (DIEP) flap reconstruction. If bilateral DIEP flap reconstruction is performed in the treatment arm, ORASIS will only be used in the first microsurgical anastomosis performed in each bilateral DIEP flap reconstruction; only the breast reconstructed with the use of ORASIS will be assessed. In both study arms, surgeons will perform end-to-end anastomosis using current standard-of-care techniques. This will include the formation of anastomoses between the deep inferior epigastric artery (DIEA) and internal mammary artery (IMA) in the antegrade direction of blood flow using 8-0 nylon sutures, as well as the deep inferior epigastric vein (DIEV) perforators and internal mammary vein (IMV).",[18],"Device: Use of ORASIS Device",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Use of ORASIS Device","The study intervention is the use of the ORASIS device during Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction. ORASIS is a dual irrigation and suction device that can be placed in the surgical field during the formation of microsurgical anastomoses. The device was previously registered with the Food and Drug Administration (FDA) under registration number 878.4200; the device is currently not registered with the FDA as it is pending renewal. The device is manufactured by a partner company (Spectroplast\u002FRicoh UK) with compliance to international quality standards. The manufacturer has successfully implemented the ISO 9001 Quality Management System across operational areas following a comprehensive audit process that supports compliance with FDA Current Good Manufacturing Practice (cGMP) requirements (21 CFR Part 820) for Class I medical devices. Spectroplast\u002FRicoh UK is certified under FDA ISO 10993 standards for biological evaluation of medical devices.",[14],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Joey Liang","CONTACT","4252097705","joey.liang@duke.edu",{"name":32,"role":28,"phone":12,"phoneExt":12,"email":33},"Ash Patel, MB ChB","ash.patel@duke.edu",[35,51],{"facility":36,"status":12,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Duke University Medical Center","Durham","North Carolina","27710","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-78.89862,35.99403,{"lat":46,"lon":45},[49],{"name":27,"role":28,"phone":50,"phoneExt":12,"email":30},"425-209-7705",{"facility":52,"status":12,"city":53,"state":38,"zip":54,"country":40,"countryCode":41,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Duke Raleigh Hospital","Raleigh","27609",{"type":43,"coordinates":56},[57,58],-78.63861,35.7721,{"lat":58,"lon":57},[61],{"name":27,"role":28,"phone":50,"phoneExt":12,"email":30},{"type":63,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100644558","orasis-in-breast-reconstruction-100644558",false,"NCT07670754","ORASIS in Breast Reconstruction","ORASIS and Microsurgical Anastomosis Outcomes in DIEP Flap Breast Reconstruction: A Crossover Randomized Controlled Trial","Inclusion:\n\n* Female Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction patients who have received a prior mastectomy (either unilateral or bilateral) on the breast undergoing reconstruction\n* Patients who received mastectomies for oncologic or prophylactic indications\n* Patients receiving either immediate or delayed DIEP flap breast reconstruction\n* Age 18 or older at the time of patient consent and DIEP flap surgery\n\nExclusion:\n\n* History of any prior tissue expander placement or breast reconstruction on the breast undergoing DIEP flap reconstruction\n* Patients receiving DIEP flap breast reconstruction for indications other than oncologic or prophylactic post-mastectomy breast reconstruction\n* Under the age of 18 at the time of patient consent or DIEP flap surgery","FEMALE","18 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","The purpose of this study is to assess the use of ORASIS during microsurgical anastomosis formation in Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction and its potential effects on surgical precision, surgeon efficiency, and anastomosis outcomes. The investigators hypothesize that the use of ORASIS will decrease the amount of time needed to perform microsurgical anastomoses, reduce interruptions for irrigation and suction, and increase the quality of anastomoses in DIEP flap breast reconstruction.",[81,82,83],"DIEP Flap","Breast Reconstruction","Breast Cancer",[81,82,83],"NOT_YET_RECRUITING","2026-06-29",{"date":88,"type":89},"2026-07-01","ACTUAL",{"date":91,"type":75},"2026-12",{"date":93,"type":75},"2027-12",{"name":5,"class":6},2]