Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 5:27 PM
Study NCT ID:
NCT04627103
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2020-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '12 months', 'description': 'Weight loss measured as a percent of total body weight (TBW)'}], 'secondaryOutcomes': [{'measure': 'Percent Responders', 'timeFrame': '12 months', 'description': 'Percent responders; i.e. percent of subjects losing at least 10% TBW'}, {'measure': 'Excess Weight Loss Measures', 'timeFrame': '12 months', 'description': 'Excess weight loss (EWL)'}, {'measure': 'Absolute Weight Loss Measures', 'timeFrame': '12 months', 'description': 'Absolute weight loss'}, {'measure': 'BMI - Weight Loss Measures', 'timeFrame': '12 months', 'description': 'Change in BMI'}, {'measure': 'Fasting Glucose', 'timeFrame': '12 months', 'description': 'Mean change in fasting glucose'}, {'measure': 'Hemoglobin A1c', 'timeFrame': '12 months', 'description': 'Mean change in Hemoglobin A1c'}, {'measure': 'Diabetes Remission and/or Improvements', 'timeFrame': '12 months', 'description': 'Proportion of subjects experiencing diabetes remission and/or improvements'}, {'measure': 'Diabetes Medication Dosage and Frequency Changes', 'timeFrame': '12 months', 'description': 'Mean change in the dosage and frequency of diabetes medications from baseline'}, {'measure': 'Serum Lipids', 'timeFrame': '12 months', 'description': 'Mean change in serum lipids'}, {'measure': 'Blood Pressure Changes', 'timeFrame': '12 months', 'description': 'Mean percent change in systolic/diastolic blood pressure'}, {'measure': 'Liver Changes using Fibroscan', 'timeFrame': '12 months', 'description': 'Change in Controlled Attenuation Parameter (CAP) Scores from baseline'}, {'measure': 'Nutritional Status', 'timeFrame': '12 months', 'description': 'Nutritional Status: changes in pre-albumin levels'}, {'measure': 'Albumin - Nutritional Status', 'timeFrame': '12 months', 'description': 'Nutritional Status: changes in albumin levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Metabolic Disease', 'Sleeve Gastrectomy'], 'conditions': ['Obesity', 'Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.', 'detailedDescription': 'Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19-65 years at screening\n* Body mass index (BMI) ≥35 and ≤50\n* T2DM diagnosis ≥6 months but \\< 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but \\< 10.0% at time of enrollment.\n* HbA1c must be stable over a 3-month period.\n* Weight stable over 3-month period\n* Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled\n* Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years\n* If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period\n* Able to understand and sign informed consent documents.\n\nExclusion Criteria:\n\n* Known or suspected allergy to nickel or titanium or nitinol\n* Type 1 diabetes or poorly controlled type 2 diabetes\n* Use of injectable insulin\n* Any documented conditions for which endoscopy would be contraindicated\n* Contraindication to general anesthesia\n* History of chronic gastrointestinal disease\n* Congenial or acquired anomalies of the GI tract\n* Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.\n* Uncontrolled hypertension\n* Pre-existing severe comorbid cardio-respiratory disease\n* History of chronic gastrointestinal disease\n* Specific genetic or hormonal cause of obesity\n* Recent tobacco/nicotine product cessation (within 3 months prior)'}, 'identificationModule': {'nctId': 'NCT04627103', 'briefTitle': 'Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'GI Windows, Inc.'}, 'officialTitle': 'A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'GIW 20-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device Placement', 'description': 'The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed.', 'interventionNames': ['Device: Self Forming Magnetic (SFM) Anastomosis System']}], 'interventions': [{'name': 'Self Forming Magnetic (SFM) Anastomosis System', 'type': 'DEVICE', 'description': 'The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.', 'armGroupLabels': ['Device Placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'QEII Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GI Windows, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}