Efficacy and Safety of EndoBar Bariatric Embolization for Weight Management in People With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
To evaluate the efficacy and safety of the Endobar gastric embolization system for the treatment of obesity before continuing to a larger Pivotal Trial.
Investigational Device The investigational device in this clinical study is the Endobar Infusion Catheter System - a disposable system consisting of an occlusion balloon catheter, a Smart Manifold delivery system.
Study Design/Planned Number of Subjects This study is a prospective, sham controlled, single-blind 12-month trial with 1:1 randomization. A maximum of 40 subjects (obese men and women who have a body mass index (BMI) of 35.0-50.0 kg/m2) will be enrolled in the study. Eligible subjects will be randomized to treatment with Endobar Therapy (n = 20) or sham procedure control (n = 20). Endobar Therapy involves catheter-based embolization of the left gastric artery. All subjects in both Endobar Therapy and Sham Control groups will receive Lifestyle Therapy (behavioral and diet education). At the end of 6 months all subjects randomized to the Sham Control group will receive catheter-based embolization of the left gastric artery. Both Endobar Therapy and Sham Control crossover to Endobar Therapy groups will be followed for a total of 12 months.
Study Duration The duration of the study is expected to last approximately 18 months from the first enrollment . An additional 12 months to the study closeout after the last follow-up.
详细描述
STUDY OBJECTIVES Objective The objective of this study is to conduct a sham controlled randomized trial to evaluate the efficacy and safety of the Endobar System for the treatment of obesity. Efficacy, Safety, and secondary outcomes will be evaluated at 6 and 12 months to allow expansion of the investigation into a larger, pivotal clinical study.
Study Design This is a prospective randomized, single blind, active treatment and sham controlled, single-center trial . After the informed consent and screening process are completed, all subjects who are eligible and wish to participate in the study will undergo baseline testing. Those who complete baseline testing will be randomized to either Endobar Therapy (ET) or Sham Treatment (ST) for 52 weeks. Both groups will be given lifestyle therapy for weight loss, which involves treatment with a behavioral education weight loss program delivered as 19 individual sessions in person over 52 weeks. Endobar Therapy involves catheter-based embolization of the left gastric artery. After 26 weeks, the ET group will continue to be monitored for an addition 26 weeks and the ST subjects will be given ET and monitored for 26 weeks. The duration of the entire study will be 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- Interventional Group: These subjects will undergo catheter-based embolization.
- Sham Control Group: These subjects will not undergo femoral artery catheterization. Instead, lidocaine will be injected subcutaneously at the femoral artery site in the Sham Control group. Since all patients will have received at least sedation, they will not be aware of what has been done, and thus be blind to their treatment assignment
入排标准
- 年龄范围
- 21 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• BMI 35.0-50.0 kg/m2 at time of screening
- •Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit.
- •Willing and able to provide informed consent
排除标准
- •• Previous bariatric, gastric pancreatic, hepatic, and/or splenic surgery
- •History of duodenal or gastric ulcers or regularly taking medications (therapy >1 day per week) that can cause ulcers (e.g., non-steroidal anti-inflammatory drugs)
- •Prior radiation to the upper abdomen
- •Prior embolization to the stomach, spleen or liver
- •Portal venous hypertension
- •Active H. pylori infection
- •Uncontrolled hypertension (> 160/100 with or without medication).
- •Diabetes (determined by medical history, fasting blood glucose or results of an oral glucose tolerance test)
- •Serum triglyceride > 400 mg/dL at screening.
- •Class 4 or 5 surgical risk based on standard ASA criteria (Saklad M. Grading of patients for surgical procedures. Anesthesiol. 1941; 2:281-4).
- •Severe pulmonary or cardiovascular disease defined as a history or evidence of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome, coronary revascularization, heart failure requiring medications, history of sudden cardiac death, or NYHA (New York Heart Association) class III or IV heart failure (defined below):
- •Class III: patients with marked limitation of activity; they are comfortable only at rest.
- •Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
- •Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5 at screening).
- •Anemia (Hb < 10.0 g/dL) at screening.
- •Malignancy in the last 5 years (except for non-melanoma skin cancer).
- •Evidence of other significant organ system dysfunction (e.g. cirrhosis, renal failure)
- •Pregnant or lactating.
- •History of substance abuse in last 3 years.
- •Thyroid Stimulating Hormone (TSH) >2.0 x upper limit of normal at screening.
- •Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 5 years.
- •Taking diuretic medication for congestive heart failure or edema.
- •Evidence of significant mucosal inflammation, ulceration or ischemia detected on endoscopy, and those with unsuitable left gastric anatomy as judged by the study site physician will be excluded
- •Psychiatric illness that could affect compliance with the study, as judged by the site principle investigator.
- •Unable to complete screening requirements (compliance with visits and dietary record)
- •Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
- •Chronic abdominal pain that would potentially complicate management.
- •Unstable weight (>3% change; self-reported) over the previous 2 months at time of screening.
- •Subjects whom the site investigator, research team, or the study medical monitor feel is not able to participate in the study for any reason, including poor general health or unable/unwilling to follow the study protocol.
结局指标
主要结局
Weight Loss
时间窗: 1) 6 months post-procedure/sham and 2) 12 months post-procedure
1. Difference in percent total body weight (% TBWL) loss at 6 months between the Sham Control and Endobar Therapy groups. This is calculated as the difference in body weight from baseline to 6 months, relative to the baseline weight (i.e, initial weight - 6 month weight / initial weight) x 100%). The mean (i.e., average) total body weight loss of both groups was compared to assess whether there was a meaningful difference. 2. Percent total body weight loss (%TBWL) at 12 months in the group randomized to the initial Endobar Therapy alone. This is calculated as the difference in body weight from baseline to 12 months, relative to the baseline weight (i.e, initial weight - 12 month weight / initial weight) x 100%).
Number of Patients With Adverse Events
时间窗: 12 months post-randomization
The Incidence of device-, procedure- and therapy-related adverse events up to 12 months post-procedure.
Absolute Weight Loss (kg)
时间窗: 6 months post-procedure/sham and 12 months post-procedure
6-month change: The absolute difference in the initial and 6-month weight (kg) (i.e., initial - 6 month weight). These changes were averaged for each group and compared between the two groups to assess whether there was a meaningful difference. 12-month change: The absolute difference in the initial and 12-month weight (kg) (i.e., initial - 12 month weight).
次要结局
- 6 Month Change in Lipids(6 months post-procedure/sham)
- Percent Excess Body Weight (%EBWL) Loss(1) 6 months post-procedure/sham and 2) 12 months post-procedure)
- Number of Patients With Weight Loss ≥5%(6 months post-procedure/sham)
- 6 and 12 Month Change in Blood Pressure(6 months post-procedure/sham and 12 months post-procedure)