[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576414":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":62,"collaborators":65,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":17,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":40,"whyStopped":17,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Brazilian Institute of Robotic Surgery","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Conventional Insufflator and Trocar","Subjects enrolled in this study arm will undergo robot-assisted radical prostatectomy using a conventional CO2 insufflation system. This system maintains standard intra-abdominal pressure (12-15 mmHg) and is widely used in clinical practice.",[12],"Device: The Conventional Insufflation System",{"label":14,"type":15,"description":16,"interventionNames":17},"AirSeal® System-Interventional","EXPERIMENTAL","Subjects enrolled in this study arm will undergo robot-assisted radical prostatectomy using the AirSeal® System. The device enables stable pneumoperitoneum at ultra-low pressures (6-8 mmHg), aiming to reduce complications and improve surgical outcomes.",null,[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"DEVICE","The Conventional Insufflation System","The Conventional Insufflation System employs standard CO2 insufflation techniques for maintaining intra-abdominal pressure during laparoscopic and robotic surgeries. It serves as the base for comparison with the AirSeal® System.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":17,"otherNames":17},"AirSeal® System","The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple-lumen filtered tube set, and a valve-free trocar (AirSeal® Access Port). This innovative system allows peritoneal access and pneumoperitoneum maintenance without a mechanical seal, reducing CO2 usage and associated complications.",[28],{"name":29,"affiliation":5,"role":30},"NILO J. MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":17,"email":36},"NILO JORGE LEÃO COORDENADOR","CONTACT","+55 71 2626-3030","ibcrpesquisa@gmail.com",[38,55],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Instituto Brasileiro de Cirurgia Robotica","RECRUITING","Salvador","Estado de Bahia","43017030","Brazil","BR",{"type":47,"coordinates":48},"Point",[49,50],-38.49096,-12.97563,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":35,"phoneExt":17,"email":36},"NILO J COORDENADOR, MD",{"facility":56,"status":40,"city":41,"state":42,"zip":17,"country":44,"countryCode":45,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Hospital Mater Dei Salvador",{"type":47,"coordinates":58},[49,50],{"lat":50,"lon":49},[61],{"name":29,"role":34,"phone":35,"phoneExt":17,"email":36},{"type":30,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"NILO JORGE CARVALHO LEÃO BARRETO","MD",[66],{"name":56,"class":67},"UNKNOWN","100576414","phase-4-impact-of-using-the-airseal-system-with-ultra-low-pneumoperitoneum-in-patients-undergoing-robot-assisted-radical-prostatectomy-a-prospective-comparative-randomized-clinical-study-100576414",false,"NCT06784986","Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.","ARCO2","Inclusion Criteria:\n\n* Patients with prostate cancer who will undergo robotic prostatectomy;\n\nExclusion Criteria:\n\n* Patients over 65 and under 18 years of age;\n* Patients allergic to NSAIDs and\u002For Morphine and\u002For Tramadol;\n* Patients with chronic renal failure;\n* Patients with recurrence, metastasis and other existing neoplasms.","MALE","18 Years","65 Years",{"count":79,"type":80},200,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","The AirSeal platform has been evaluated in urological surgeries, mainly in cases of malignant diseases 5,6. However, there is still a lack of data demonstrating the possible benefits of its use, which justifies the conduct of this research in order to aggregate such knowledge. Therefore, the objective of this prospective pilot study is to compare and evaluate the role of low-pressure pneumoperitoneum with the AirSeal system in patients with prostate cancer undergoing robot-assisted prostatectomy with those undergoing the procedure with the conventional insufflation system. We seek to provide more data on the use of AirSeal, which is associated with shorter operative times, shorter hospital stays and a lower probability of complications. In addition, we aim to ratify the effectiveness and cost-benefit of using the AirSeal system.",[86,87,88,89],"Prostate Carcinoma","Prostate Neoplasm","Pain Intensity Assessment","Quality of Life (QOL)",[91,92,93],"pneumoperitoneum","airseal","pneumoperitoneum in prostate neoplasm","2025-01-15",{"date":96,"type":97},"2025-01-20","ACTUAL",{"date":99,"type":80},"2025-02",{"date":101,"type":80},"2026-02-15",{"name":5,"class":6},2]