Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 10
- 主要终点
- Mean Percent Excess Weight Loss (%EWL)
研究概览
简要总结
This research study is being performed to find out if a new device, AspireAssist Aspiration Therapy System, can help people with obesity to lose weight without causing too many side effects.
详细描述
The Aspiration process works by "correcting" meal portions after eating by removing some of the food left in your stomach 20 minutes after your meal, which reduces the number of calories absorbed by your body. This is done through a tube placed through the abdomen into the stomach with a small valve attached at the surface of your skin. An aspiration system will attach to that valve after each major meal of the day and allow you to remove a portion of that meal.
During this study you will also be provided with Lifestyle therapy which includes behavioral therapy, diet and physical activity education. This Lifestyle therapy will also be provided to the participants who do not receive the AspireAssist so that the two groups can be compared and the benefit of aspiration for weight loss can be determined.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Measured BMI of 35.0-55.0 kg/m2 at time of screening.
- •21- 65 years of age (inclusive) at time of screening.
- •Failed attempt for a duration equal to 3-months at weight loss by alternative approaches (e.g. supervised or unsupervised diets, exercise, behavioral modification programs).
- •Stable weight (<3% change in self-reported weight) over the previous 3 months 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 in English and comply with the protocol.
排除标准
- •Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
- •Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
- •History of refractory gastric ulcers
- •Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.
- •History of radiation therapy to the chest or abdomen
- •Uncontrolled hypertension (blood pressure >160/100).
- •Diabetes treated with insulin or sulfonylurea medications
- •Any change in diabetes medication in previous 3 months
- •Hemoglobin A1C >9.5%
- •History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure (defined below):
- •Class III: patients with marked limitation of activity and who are comfortable only at rest Class IV: patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity
- •Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5)
- •Anemia (Hemoglobin <11.0 g/dL in women and <12.5 g/dL in men)
- •Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal
- •Thyroid Stimulating Hormone (TSH) >1.5 x upper limit of normal at screening.
- •Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values).
- •History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma)
- •Pregnant or lactating
- •Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)
- •Night Eating Syndrome (diagnosed by EDE)
- •Serum potassium < 3.8 mEq/L
- •Chronic abdominal pain that would potentially complicate the management of the device
- •Taking a GLP-1 agonist < 6 months.
- •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 24 months.
- •Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
- •Self- reported history of substance abuse in last 3 years.
- •Malignancy in the last 5 years (except for non-melanoma skin cancer).
- •Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
- •At high risk of having a medical complication from the endoscopic procedure or Aspiration Therapy weight loss program for any reason, including poor general health or severe organ dysfunction, such as cirrhosis or renal dysfunction (GFR <60 mL/min/1.73 m2 at screening, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation).
研究组 & 干预措施
Aspiration Therapy
Aspiration Therapy and Lifestyle Therapy
干预措施: Aspiration Therapy (AspireAssist) (Device)
Aspiration Therapy
Aspiration Therapy and Lifestyle Therapy
干预措施: Lifestyle Therapy (Behavioral)
Lifestyle Therapy
Lifestyle Therapy only
干预措施: Lifestyle Therapy (Behavioral)
结局指标
主要结局
Mean Percent Excess Weight Loss (%EWL)
时间窗: 52 weeks
The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.
% of Subjects Who Achieve >25% EWL
时间窗: 52 weeks
The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve \> 25% EWL.
次要结局
- Change in Number of Subjects on Dyslipidemia Medications(52 weeks)
- Change in Medication for Hypertension(52 weeks)
- Mean Percent Change in Blood Pressure(52 weeks)
- Procedural Success(52 weeks)
- Change in Medications for Dyslipidemia(52 weeks)
- Mean Percent Total Body Weight Loss(52 weeks)
- Mean Percent Change in Serum Lipids(52 weeks)
- Change in Number of Subjects on Hypertension Medication(52 weeks)
- Change in Number of Subjects on Diabetes Medication(52 weeks)
- Mean Change in Score for IWQOL Questionnaire(52 weeks)
- Change in Medications for Type 2 Diabetes(52 weeks)
- Percent of Subjects With ≥10% Total Body Weight Loss(52 weeks)
- Mean Change in Hemoglobin A1C(52 weeks)