Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

Conditions
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Obesity

Intervention / Treatment
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* Device: Aspiration Therapy (AspireAssist)
* Behavioral: Lifestyle Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspiration Therapy<br>Aspiration Therapy and Lifestyle Therapy | Device: Aspiration Therapy (AspireAssist)<br>* Use of the AspireAssist device in aspiration therapy<br>* Other names: AspireAssist Aspiration Therapy System;Behavioral: Lifestyle Therapy<br>* Lifestyle therapy is a behavioral, diet and physical activity education program<br>* Other names: Lifestyle Behavioral Therapy;|
| Active Comparator: Lifestyle Therapy<br>Lifestyle Therapy only | Behavioral: Lifestyle Therapy<br>* Lifestyle therapy is a behavioral, diet and physical activity education program<br>* Other names: Lifestyle Behavioral Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Excess Weight Loss (%EWL) | 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. | 52 weeks | 
| % of Subjects Who Achieve >25% EWL | The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL. | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Total Body Weight Loss | i) Mean percent absolute weight loss in AT compared to Control group | 52 weeks | 
| Percent of Subjects With ≥10% Total Body Weight Loss | ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group | 52 weeks | 
| Mean Percent Change in Serum Lipids | iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group | 52 weeks | 
| Mean Percent Change in Blood Pressure | iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group | 52 weeks | 
| Mean Change in Score for IWQOL Questionnaire | v) Impact of Weight on Quality of Life (IWQOL) questionnaire total score Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points. | 52 weeks | 
| Mean Change in Hemoglobin A1C | vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint. | 52 weeks | 
| Procedural Success | vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy | 52 weeks | 
| Change in Medication for Hypertension | Percent change in the number of medications taken by subjects for hypertension | 52 weeks | 
| Change in Medications for Dyslipidemia | Percent change in the number of medications taken by subjects for dyslipidemia | 52 weeks | 
| Change in Medications for Type 2 Diabetes | Percent change in the number of medications taken by subjects for Type 2 Diabetes | 52 weeks | 
| Change in Number of Subjects on Hypertension Medication | Percent change in the number of subjects on Hypertension medication | 52 weeks | 
| Change in Number of Subjects on Dyslipidemia Medications | Percent change in the number of subjects on Dyslipidemia medications | 52 weeks | 
| Change in Number of Subjects on Diabetes Medication | Percent change in the number of subjects on Diabetes medication | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, obese, weight loss