[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100273314":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":55,"collaborators":23,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":23,"maxAge":67,"enrollmentInfo":68,"targetDuration":23,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":81,"whyStopped":23,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Akron Children's Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"LOW AIS Pressure AirSeal®","AIS with an insufflation pressure target of 9mmHg ±1mmHg",[12],"Device: AirSeal® Insufflation System (AIS)",{"label":14,"type":6,"description":15,"interventionNames":16},"HIGH AIS Pressure AirSeal®","AIS with an insufflation pressure target of 15mmHg ±1mm",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","AirSeal® Insufflation System (AIS)","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). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier.",[14,9],null,[25],{"name":26,"affiliation":5,"role":27},"Todd Ponsky, MD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Michelle R Jacobs, MA","CONTACT","330-543-4969","mjacobs@akronchildrens.org",{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},"Sarah E Pfeiffer, MA","330-543-1327","spfeiffer@akronchildrens.org",[39],{"facility":40,"status":23,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Children's Hospital Medical Center of Akron","Akron","Ohio","44308","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-81.51901,41.08144,{"lat":50,"lon":49},[53,54],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":23,"email":37},{"type":27,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Todd Ponsky","MD","100273314","pneumoperitoneum-management-with-surgiquest-airseal-at-low-vs-higher-pressure-100273314",false,"NCT02837601","Pneumoperitoneum Management With SurgiQuest AirSeal® at Low vs. Higher Pressure","A Single Center, Prospective, Randomized, Controlled Study To Evaluate Physician Preference Related To The Use Of The Surgiquest Airseal® Insufflation System (AIS) At Low Vs. Higher Pressure For The Management Of Pneumoperitoneum","PRESSURE","Inclusion Criteria:\n\n1. Pediatric subjects (\\\u003C21 years of age)\n2. \\> 20 kg in weight;\n3. Capable and willing to provide parental Informed Consent and patient Assent;\n4. Acceptable candidate for laparoscopic surgery;\n\nExclusion Criteria:\n\n1. Active cutaneous infection or inflammation;\n2. Pre-existing immunodeficiency disorder and\u002For chronic use of systemic steroids;\n3. Uncontrolled diabetes mellitus\n4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \\\u003C 100,000 cells\u002Fmm3, baseline INR(international normalized ratio) ≥1.8, or fibrinogen level less than 150 mg\u002Fdl (if received a fibrinolytic agent within prior 24 hours);\n5. Severe co-existing morbidities having a life expectancy of less than 30 days;\n6. Currently involved in any other investigational clinical Studies;\n7. Significant anemia with a hemoglobin level less than 10 g\u002FdL or a hematocrit less than 30%;\n8. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating;\n9. Extreme morbid obesity (BMI greater than 45 kg\u002Fm2)\n10. Patients presenting with Ascites","ALL","21 Years",{"count":69,"type":70},102,"ESTIMATED","INTERVENTIONAL",[73],"NA","A prospective, randomized, controlled single-center clinical Study designed to evaluate Physician Preference related to the use of the SurgiQuest AirSeal® Insufflation System (AIS) at low vs. higher pressures for the Management of pneumoperitoneum. Subjects will be randomized in a 1:1 treatment device to control ratio into one of two (2) different study arms:\n\n1. AIS with an insufflation pressure target of 9mmHg ±1mmHg; or\n2. AIS with an insufflation pressure target of 15mmHg ±1mmHg.",[76],"Shoulder Pain",[78,76,79,80],"Laparoscopic surgical procedures","Abdominal Pain","Pediatrics","NOT_YET_RECRUITING","2020-07-10",{"date":84,"type":85},"2020-07-13","ACTUAL",{"date":87,"type":70},"2021-03",{"date":89,"type":70},"2027-11",{"name":5,"class":6},1]