[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06928545":3,"trial-entities:NCT06928545":137,"trial-summary:NCT06928545":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":27,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":50,"locations":53,"central_contacts":127,"overall_officials":134,"references":135,"see_also_links":136},"NCT06928545","GTM-007","MagDI U.S. Registry","Post-Market Assessment of the Incidence and Severity of Internal Hernia and Bowel Obstruction at One Year Following Use of the MagDI System to Create Side-to-Side Duodeno-Ileal Magnetic Compression Anastomoses (MagDI US Registry)","RECRUITING","2027-04","2026-02","2026-02-20","2025-03-28","GT Metabolic Solutions, Inc.","INDUSTRY",false,"Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.","Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).\n\nGiven the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.",[19,20,21],"Anastomosis, Surgical","Internal Hernia","Bowel Obstruction",[23,24,25],"GT Metabolic","MagDI System","Magnetic Anastomosis","OBSERVATIONAL",null,[],{"count":30,"type":31},106,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","Side-to-side duodenal-ileal anastomosis","Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System.",[24],[39],{"measure":40,"description":41,"timeFrame":42},"Incidence of Internal Hernia and Bowel Obstructions","To assess and characterize incidence and severity of internal hernia and bowel obstruction at one year in U.S. patients treated with the MagDI System compared with the pre-market study (GTM-001) and scientific literature.","From date of study index procedure through 360 days.",[],"ALL","22 Years",{"inclusion":47,"exclusion":48,"raw_text":49},[],[],"Inclusion Criteria:\n\n1. \\>21 years of age, at the time of informed consent.\n2. Body Mass Index (BMI) between 30-50 kg\u002Fm2.\n3. Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.\n4. Participant has been informed of the nature of the registry.\n\nExclusion Criteria:\n\n1\\. Participant does not provide informed consent to be enrolled and followed in the registry.",[51,52],"ADULT","OLDER_ADULT",[54,71,85,99,113],{"facility":55,"status":8,"city":56,"state":57,"zip":58,"country":59,"contacts":60,"geoPoint":68},"Ventura Advanced Surgical Associates","Ventura","California","93003","United States",[61,65],{"name":62,"role":63,"phone":64},"Hellmuth Billy","CONTACT","805-676-9100",{"name":66,"role":67},"Helmuth Billy, MD","PRINCIPAL_INVESTIGATOR",{"lat":69,"lon":70},34.27834,-119.29317,{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":59,"contacts":76,"geoPoint":82},"Baptist Healthcare System, Inc.","Louisville","Kentucky","40299",[77,80],{"name":78,"role":63,"email":79},"Candice Brunton","candice.brunton@bhsi.com",{"name":81,"role":67},"John Oldham, MD",{"lat":83,"lon":84},38.25424,-85.75941,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":59,"contacts":90,"geoPoint":96},"Ochsner Clinic Foundation","Lafayette","Louisiana","70503",[91,94],{"name":92,"role":63,"email":93},"Ashunti Pearson","aspearson@ochsner.org",{"name":95,"role":67},"Philip Gachassin, MD",{"lat":97,"lon":98},30.22409,-92.01984,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":59,"contacts":104,"geoPoint":110},"Bariatric Specialists of the Carolinas","Cary","North Carolina","27518",[105,108],{"name":106,"role":63,"email":107},"Jamie Lee Bull, PA","jbullpabsc@gmail.com",{"name":109,"role":67},"Paul Enochs, MD",{"lat":111,"lon":112},35.79154,-78.78112,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":59,"contacts":118,"geoPoint":124},"Transform Weight Loss","Lynnwood","Washington","98036",[119,122],{"name":120,"role":63,"email":121},"Josiah Billing","jbilling@transformweightloss.com",{"name":123,"role":67},"Peter Billing, MD",{"lat":125,"lon":126},47.82093,-122.31513,[128,132],{"name":129,"role":63,"phone":130,"email":131},"Lisa Griffin Vincent, PhD, MA","+1 763-200-1416","clinical@gtmetabolic.com",{"name":133,"role":63,"phone":130,"email":131},"Josh Schumacher",[],[],[],{"nct_id":4,"conditions":138,"biomarkers":140},[139],"Obesity",[],{"nct_id":4,"found":142,"summary":143,"prompt_version":153},true,{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is an observational study planning to enroll 106 participants. It is designed to collect real-world information about patients who have undergone a specific surgical procedure.","completed","MagDI U.S. Registry for Surgical Anastomosis","This study, called the MagDI U.S. Registry, is looking at people who have had a specific type of surgery using the MagDI System. The MagDI System helps create a connection between the small intestine and the first part of the small intestine (a side-to-side duodenal-ileal anastomosis) using magnetic compression. The main goal is to see how often patients develop internal hernias or blockages in their bowels (bowel obstructions) within one year after this surgery. You might be able to join if you are over 21, have a BMI between 30 and 50, and are having this specific surgery with the MagDI System at a participating U.S. center. This is an observational study, meaning researchers will collect information about your health after the procedure.","Participants will be followed for the incidence of internal hernia and bowel obstructions for 360 days after their procedure.",123,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]