Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-03 @ 9:17 PM
Study NCT ID:
NCT02786108
Status:
UNKNOWN
Last Update Posted:
2016-06-07
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bariatric Arterial Embolization for Morbid Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072001', 'term': 'Diet, Healthy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-05', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': 'Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months', 'description': 'Unit of Measure: Percentage of excess weight loss \\[%EWL\\]. The body weight will be measured within 2-4h after breakfast.'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months', 'description': 'The brachial artery blood pressure will be measured in the early hours of the morning and under the quiet situation. Unit of Measure: mmHg.'}, {'measure': 'Lipid Profile', 'timeFrame': 'Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months', 'description': 'Blood cholesterol levels, triglyceride levels and lipoprotein levels will be detected. Unit of Measure: mmol/L.'}, {'measure': 'Number of Patients with Adverse Events', 'timeFrame': 'post-op 30 days', 'description': 'Surgical complications and adverse events such as massive hemorrhage, femoral artery pseudoaneurysm, gastric mucosal ischemia and necrosis and gastric perforation, etc., will be documented.'}, {'measure': 'Ghrelin levels', 'timeFrame': 'Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months', 'description': 'Unit of Measure: pg/mL. Detection of serum Ghrelin levels will be obtained using fasting blood in the morning.'}, {'measure': 'Abdominal fat content', 'timeFrame': 'Baseline, post-op 1 month,6 months,12 months', 'description': 'Abdominal fat content detected by MRI.'}, {'measure': 'Leptin levels', 'timeFrame': 'Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months', 'description': 'Detection of serum Leptin levels will be obtained using fasting blood in the morning. Unit of Measure: pg/mL.'}, {'measure': 'Results of Gastroendoscopic Examination', 'timeFrame': 'Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months', 'description': 'Photos and clinical reports will be analyzed.'}, {'measure': 'Quality of Life Parameters Survey', 'timeFrame': '12 months', 'description': 'N/A Utilizing SF-36/ pre and post procedure to determine the changes of quality in life; everyday activities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['left gastric artery', 'embolization', 'obesity'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '29063494', 'type': 'DERIVED', 'citation': 'Bai ZB, Qin YL, Deng G, Zhao GF, Zhong BY, Teng GJ. Bariatric Embolization of the Left Gastric Arteries for the Treatment of Obesity: 9-Month Data in 5 Patients. Obes Surg. 2018 Apr;28(4):907-915. doi: 10.1007/s11695-017-2979-9.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and effectiveness of left gastric artery embolization(bariatric arterial embolization) for morbid obesity. When the target vessel is blocked, some of the body's signals for feeling hungry will be suppressed and lead to weight loss.\n\nAlthough there are many ways to treat morbid obesity, surgery is currently the only effective method to be confirmed. But surgical treatment is likely to carry a high risk of treatment-related complications, such as fistula or intestinal obstruction, etc. This study is designed to help treat obesity using a method of transvascular interventional therapy, which is minimally invasive and non-surgical."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Body mass index (BMI) \\>30.\n2. No history of gastrointestinal surgery.\n3. Willing, able and mentally competent to provide written informed consent.\n4. Suitable for protocol therapy as determined by the interventional radiology Investigator.\n5. Adequate hematological, hepatic and renal function as follows:\n\n Hematological Neutrophils \\> 1.5 x 109/L Platelets \\> 100 x 109/L INR \\<1.5 Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L Renal Estimated GFR \\> 60ml/min.1.73m2\n6. Aged between18 and 65 years old.\n7. More than one year's follow-up can be obtained reliably\n\nExclusion Criteria:\n\n1. Prior history of gastric pancreatic, hepatic, and/or splenic surgery\n2. Prior embolization to the stomach, spleen or liver\n3. Prior or current history of peptic ulcer disease\n4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.\n5. Portal venous hypertension or cirrhosis\n6. Less than 18 years or older than 65 years of age\n7. Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of \\< 60 milliliters per minute an estimated glomerular filtration rate of \\< 60 milliliters per minute\n8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease\n9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media\n10. Patients with certain psychiatric disorders such as schizophrenia, borderline personality disorder, and uncontrolled depression, and mental/cognitive impairment that limits the individual's ability to understand the proposed therapy.\n11. Patients currently taking or requiring chronic use of NSAID or steroid medications"}, 'identificationModule': {'nctId': 'NCT02786108', 'acronym': 'BAEMO', 'briefTitle': 'Bariatric Arterial Embolization for Morbid Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Bariatric Arterial Embolization for Morbid Obesity', 'orgStudyIdInfo': {'id': '2015ZDSYLL068.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'left gastric artery embolization', 'description': 'Patients undergoing left gastric artery embolization', 'interventionNames': ['Procedure: left gastric artery embolization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy diet and exercise', 'description': 'Patients undergoing healthy diet and exercise', 'interventionNames': ['Behavioral: healthy diet and exercise']}], 'interventions': [{'name': 'left gastric artery embolization', 'type': 'PROCEDURE', 'armGroupLabels': ['left gastric artery embolization']}, {'name': 'healthy diet and exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['healthy diet and exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhibin Bai', 'role': 'CONTACT', 'email': 'baizhibin1004@sina.com'}], 'facility': 'Zhongda Hospital,Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Zhibin Bai', 'role': 'CONTACT', 'email': 'baizhibin1004@sina.com'}], 'overallOfficials': [{'name': 'Gao-jun Teng, Ph.D,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology & Chair,Department of Radiology', 'investigatorFullName': 'Gao-jun Teng', 'investigatorAffiliation': 'Zhongda Hospital'}}}}