[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492115":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":32,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":21,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":21,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":21,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"AbSolutions Med Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"REBUILD","EXPERIMENTAL","REBUILD is an investigational medical device (bioabsorbable anchor and deployment instruments) used with third party suture to close the abdominal wall. As the suture and Anchor absorb, abdominal wall forces gradually transfer to the organizing scar, one of the tenets of successful wound tensile strength acquisition. After full absorption, no permanent material remains that would otherwise alter normal anatomy, anisotropic properties, or compliance of the abdominal wall (Deeken, 2017).",[13],"Device: REBUILD",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","3.1.1. REBUILD is an investigational medical device provided as a sterile, single use set containing 10 suture Anchors and two non-implantable Carriers, with reusable stainless-steel instruments for deployment supplied separately.",[9],[20],"REBUILD Bioabsorbable, The REBUILD System",null,[23,28],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Dan Jacobs, MD","CONTACT","650-303-6140","djacobs@absolutionsmed.com",{"name":29,"role":25,"phone":30,"phoneExt":21,"email":31},"Kathryn Kelley, RN, BSN","925-360-5173","kkelley@absolutionsmed.com",[33],{"facility":34,"status":21,"city":35,"state":21,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Rambam Health Care Campus","Haifa","3109601","Israel","IL",{"type":40,"coordinates":41},"Point",[42,43],34.99928,32.81303,{"lat":43,"lon":42},[46,50,54,56],{"name":47,"role":25,"phone":48,"phoneExt":21,"email":49},"Haim Gilshtein, MD","+050-206-2089","h.gilshtein@rambam.health.gov.il",{"name":51,"role":25,"phone":52,"phoneExt":21,"email":53},"Ortal Bar On","+972 50-206-1391","O_Bar_On@rambam.health.gov.il",{"name":47,"role":55,"phone":21,"phoneExt":21,"email":21},"PRINCIPAL_INVESTIGATOR",{"name":57,"role":58,"phone":21,"phoneExt":21,"email":21},"David Hochstein, MD","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[62],{"name":63,"class":64},"Cogent Technologies Corporation","UNKNOWN","100492115","the-rebuild-trial-closure-of-the-abdominal-wall-100492115",false,"NCT05687942","The REBUILD Trial: Closure of the Abdominal Wall","The REBUILD Trial: A Prospective, Multi-Center, Single Arm Study Using REBUILD for Abdominal Wall Closure","Inclusion Criteria:\n\n1. Patient is 22-80 years of age\n2. Patient is undergoing a midline laparotomy procedure\n3. Patient is able to provide written informed consent\n4. Patient is able and willing to comply with all study requirements\n\nExclusion Criteria:\n\n1. Patient has BMI \\> 40\n2. Patients with available imaging measuring abdominal wall thickness \\\u003C 5.7 mm or \\> 16.5 mm\n3. Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months\n4. Patient has mesh at the site of deployment\n5. Patient has an ostomy within the planned midline closure site (4 cm either side of midline)\n6. Patient has a CDC wound classification of Class IV\n7. Patient has devitalized tissue present at the intended surgical site\n8. Patient has any co-morbid conditions determined by the investigator to place them at a high risk of complications (e.g., severe cardiovascular disease, congestive heart failure NYHA Class III or IV, end-stage renal failure, liver cirrhosis, connective tissue disorder, poorly managed diabetes)\n9. Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)\n10. Patient has history of radiation therapy targeting the abdominal wall\n11. Patient is participating in a concurrent investigational medical device study\n12. Patient is pregnant or planning on becoming pregnant during the study period\n13. Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits","ALL","22 Years","80 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"NA","The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance.\n\nParticipants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.",[83],"Surgical Incision",[85,86,87,88,9],"abdominal wall closure","hernia","laparotomy","suture tension","NOT_YET_RECRUITING","2023-01-18",{"date":92,"type":93},"2023-01-20","ACTUAL",{"date":95,"type":77},"2023-03",{"date":97,"type":77},"2026-06",{"name":5,"class":6},1]