Bariatric Arterial Embolization for Morbid Obesity
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Weight Loss
研究概览
简要总结
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.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) >
- •No history of gastrointestinal surgery.
- •Willing, able and mentally competent to provide written informed consent.
- •Suitable for protocol therapy as determined by the interventional radiology Investigator.
- •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
- •Aged between18 and 65 years old.
- •More than one year's follow-up can be obtained reliably
排除标准
- •Prior history of gastric pancreatic, hepatic, and/or splenic surgery
- •Prior embolization to the stomach, spleen or liver
- •Prior or current history of peptic ulcer disease
- •Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
- •Portal venous hypertension or cirrhosis
- •Less than 18 years or older than 65 years of age
- •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
- •Major comorbidity such as cancer, significant cardiovascular disease, or peripheral arterial disease
- •Pregnant or intend to become pregnant within one year Known history of allergy to iodinated contrast media
- •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.
- •Patients currently taking or requiring chronic use of NSAID or steroid medications
结局指标
主要结局
Weight Loss
时间窗: Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months
Unit of Measure: Percentage of excess weight loss \[%EWL\]. The body weight will be measured within 2-4h after breakfast.
次要结局
- Blood pressure(Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months)
- Lipid Profile(Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months)
- Number of Patients with Adverse Events(post-op 30 days)
- Ghrelin levels(Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months)
- Leptin levels(Baseline, post-op 1 month, 3 months, 6 months,9 months,12 months)
- Quality of Life Parameters Survey(12 months)
- Abdominal fat content(Baseline, post-op 1 month,6 months,12 months)
- Results of Gastroendoscopic Examination(Baseline, post-op 1 week, post-op 1 month, 3 months, 6 months,9 months,12 months)
研究者
Gao-jun Teng
Professor of Radiology & Chair,Department of Radiology
Zhongda Hospital