Gastric Arterial Embolization for Weight Loss
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 主要终点
- Adverse events
研究概览
简要总结
Title: Embolization of Gastric Arterial Supply for Weight Loss
Sample size:
10 patients
Study Population: Morbidly obese patients who were seen by the bariatric surgery program at Toronto Western Hospital but are either not interested or not eligible for surgery.
Study Design:
Single center, randomized, prospective, non-blinded pilot study.
Study Duration:
12 months (November 2015 - December 2015).
Agent:
150-250 micron polyvinyl alcohol particles
Primary objective:
To further evaluate the safety of embolization of the left gastric and gastroepiploic arteries. To determine if either or both will result in significant weight loss and decrease in waist circumference among obese patients.
Primary objective measure:
The number of adverse events in a 1 year period will be recorded. The weight change from baseline will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet standard eligibility criteria for bariatric surgery. BMI of >= 40 -or- BMI of >=35 with one of the following comorbid conditions: hypertension, type 2 diabetes, obstructive sleep apnea, coronary artery disease
排除标准
- •Unable to provide informed consent (legally authorized representative is acceptable) Unable or unwilling to come for follow up appointments Age < 18 or >80 Weight >400 lbs or 180kg due to weight limits on angiographic tables Moderate or severe allergy to iodinated contrast media not amenable to premedication as defined by the ACR contrast guidelines Pregnant, breastfeeding or actively trying to become pregnant in the next year Inability to lie flat for the duration of the procedure Limited life expectancy < 1 year Patient enrolled in another interventional study, they will be permitted to enter this study 30 days after reaching the prior studies primary endpoint Arterial anatomy not feasible for intervention based on investigator assessment
- •Gastrointestinal
- •Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis Prior history of gastric surgery, embolization or radiation Prior or current history of peptic ulcer disease Significant risk factors for peptic ulcer disease including daily NSAID use, active smoking or active H. Pylori infection Abnormal upper endoscopy Hepatic Cirrhosis Portal venous hypertension Hepatic Bilirubin > 2.0 mg/dL Albumin < 2.5 g/L
- •Cardiovascular
- •Known aortic pathology such as aneurysm or dissection Peripheral arterial disease
- •Renal insufficiency as evidenced by estimated GFR < 60ml/min.1.73m2
- •Hematologic/Immunologic/Oncologic/Infectious
- •Acute or chronic infection Active cancer or prior history of cancer <10 years ago Autoimmune disease requiring immunosuppression Neutrophils < 1.5 x 10^9/L Platelets < 50 x 10^9/L INR >1.7
- •Psychiatric
- •Major diagnosed psychiatric comorbidities such a major depressive disorder, schizophrenia, bipolar disorder that are deemed to likely interfere with follow up History of an eating disorder such as anorexia or bulimia
结局指标
主要结局
Adverse events
时间窗: 1 year
Adverse events
次要结局
- Weight(1 year)
- Cardiovascular risk factors(1 year)
研究者
Martin Simons
BSc, MD, FRCPC, FSIR
University Health Network, Toronto