[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480390":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":136,"collaborators":138,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":20,"eligibilityCriteria":159,"healthyVolunteers":156,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":20,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Eclipse Regenesis, Inc.","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Eclipse XL1 Coil Treatment Group","EXPERIMENTAL","All subjects will be assigned to the XL1 Coil treatment group.",[13],"Device: Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome","The surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Andre Bessette","CONTACT","(617)249-0955","andre@eclipseregenesis.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Eric Bannon","(781)710-8243","ebannon@alvamed.com",[32,53,68,84,100,117],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Lucile Packard Children's Hospital Stanford","RECRUITING","Palo Alto","California","94303","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-122.14302,37.44188,{"lat":44,"lon":43},[47,51],{"name":48,"role":24,"phone":49,"phoneExt":20,"email":50},"Shweta Namjoshi, MD","(650) 721-2250","namjoshi@stanford.edu",{"name":48,"role":52,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":34,"city":55,"state":36,"zip":56,"country":38,"countryCode":39,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of California San Francisco","San Francisco","94143",{"type":41,"coordinates":58},[59,60],-122.41942,37.77493,{"lat":60,"lon":59},[63,67],{"name":64,"role":24,"phone":65,"phoneExt":20,"email":66},"Matthew Lin, MD","(415) 476-0972","Matthew.Lin@ucsf.edu",{"name":64,"role":52,"phone":20,"phoneExt":20,"email":20},{"facility":69,"status":34,"city":70,"state":36,"zip":71,"country":38,"countryCode":39,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Stanford University School of Medicine","Stanford","94304",{"type":41,"coordinates":73},[74,75],-122.16608,37.42411,{"lat":75,"lon":74},[78,82],{"name":79,"role":24,"phone":80,"phoneExt":20,"email":81},"Anisha Abreo","650 723 4000","aabreo@stanford.edu",{"name":83,"role":52,"phone":20,"phoneExt":20,"email":20},"Joseph Forrester, MD",{"facility":85,"status":34,"city":86,"state":87,"zip":88,"country":38,"countryCode":39,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Children's National Hospital","Washington D.C.","District of Columbia","20010",{"type":41,"coordinates":90},[91,92],-77.03637,38.89511,{"lat":92,"lon":91},[95,99],{"name":96,"role":24,"phone":97,"phoneExt":20,"email":98},"Clarivet Torres, MD","202-476-2115","ctorres@childrensnational.org",{"name":96,"role":52,"phone":20,"phoneExt":20,"email":20},{"facility":101,"status":34,"city":102,"state":103,"zip":104,"country":38,"countryCode":39,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Boston Children's Hospital","Boston","Massachusetts","02115",{"type":41,"coordinates":106},[107,108],-71.05977,42.35843,{"lat":108,"lon":107},[111,115],{"name":112,"role":24,"phone":113,"phoneExt":20,"email":114},"Meghan Fitzgerald","(617) 355-4729","Meghan.Fitzgerald@childrens.harvard.edu",{"name":116,"role":52,"phone":20,"phoneExt":20,"email":20},"Mark Puder, MD",{"facility":118,"status":34,"city":119,"state":120,"zip":121,"country":38,"countryCode":39,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229-3026",{"type":41,"coordinates":123},[124,125],-84.51439,39.12711,{"lat":125,"lon":124},[128,132,134],{"name":129,"role":24,"phone":130,"phoneExt":20,"email":131},"Beth Cobb","405-850-1349","Beth.Cobb@cchmc.org",{"name":133,"role":52,"phone":20,"phoneExt":20,"email":20},"Michael Helmrath, MD",{"name":135,"role":52,"phone":20,"phoneExt":20,"email":20},"Paul Wales, MD",{"type":137,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[139,142,144,146,148,149,152],{"name":140,"class":141},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":143,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":145,"class":6},"Stanford University",{"name":147,"class":6},"University of California, San Francisco",{"name":101,"class":6},{"name":150,"class":151},"Lucile Packard Children's Hospital at Stanford","UNKNOWN",{"name":153,"class":151},"Children's National Health System, Washington DC","100480390","a-feasibility-study-to-evaluate-safety-and-probable-benefit-of-the-eclipse-xl1-system-for-distraction-enterogenesis-in-adult-and-pediatric-patients-with-short-bowel-syndrome-100480390",false,"NCT05535361","A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients With Short Bowel Syndrome","Inclusion Criteria:\n\n* Subject has short bowel syndrome, defined as 50% or less of expected bowel length based on subject age and\u002For height, and measured at the time of the subject's prior intestinal resection.\n* Minimum residual bowel length of 3 cm.\n* Male or female patients aged 3 mo to 65 years inclusive\n* The subject, parent or legal guardian of the subject is able to read, understand, and is willing to provide informed consent.\n* The subject or parent or legal guardian of the patient is able to understand the requirements of the study and is willing to bring the subject to all clinic visits and complete all study related procedures (as determined by the investigator).\n\nExclusion Criteria:\n\n* Ultra-short bowel syndrome defined as less than 3 cm of bowel length.\n* Diagnosed Inflammatory bowel disease-unclassified (not Crohn's or ulcerative colitis)\n* Evidence of active or prior Crohn's disease.\n* Primary intestinal failure (i.e., without loss or resection of intestinal tissue).\n* Coagulopathy, as defined by INR \\> 1.4 or platelets \\\u003C 100.\n* Known immunocompromised status including, but not limited to, individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.\n* Subject is determined by the investigator to be unsuitable for participation in this trial for any reason.","ALL","3 Months","65 Years",{"count":164,"type":165},40,"ESTIMATED","INTERVENTIONAL",[168],"NA","A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in Adult and Pediatric Patients with Short Bowel Syndrome",[171],"Short Bowel Syndrome",[173,174,175,176,177,178],"short bowel syndrome","intestinal failure","Necrotizing enterocolitis","short gut","intestinal volvulus","intestinal atresia","2025-10-03",{"date":181,"type":182},"2025-10-08","ACTUAL",{"date":184,"type":182},"2025-09-15",{"date":186,"type":165},"2028-06-30",{"name":5,"class":6},6]