Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2016-05-31
2018-05-31
Brief Summary
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Although 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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left gastric artery embolization
Patients undergoing left gastric artery embolization
left gastric artery embolization
healthy diet and exercise
Patients undergoing healthy diet and exercise
healthy diet and exercise
Interventions
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left gastric artery embolization
healthy diet and exercise
Eligibility Criteria
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Inclusion Criteria
2. No history of gastrointestinal surgery.
3. Willing, able and mentally competent to provide written informed consent.
4. Suitable for protocol therapy as determined by the interventional radiology Investigator.
5. Adequate hematological, hepatic and renal function as follows:
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
6. Aged between18 and 65 years old.
7. More than one year's follow-up can be obtained reliably
Exclusion Criteria
2. Prior embolization to the stomach, spleen or liver
3. Prior or current history of peptic ulcer disease
4. Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
5. Portal venous hypertension or cirrhosis
6. Less than 18 years or older than 65 years of age
7. 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
8. Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
9. Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
10. 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.
11. Patients currently taking or requiring chronic use of NSAID or steroid medications
18 Years
65 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
Professor of Radiology & Chair,Department of Radiology
Principal Investigators
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Gao-jun Teng, Ph.D,MD
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
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Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2015ZDSYLL068.0
Identifier Type: -
Identifier Source: org_study_id
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