Clinical trial NCT01766037: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
Official title: Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
obese
weight loss
Lead sponsor: Aspire Bariatrics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boston Medical Center
name: Brigham and Women's Hospital
name: Cornell University
name: Howard University
name: Mayo Clinic
name: Northwestern University
name: St. Mary's Medical Center
name: San Diego Veterans Healthcare System
name: University of Pennsylvania
name: Washington University School of Medicine
First posted: 2013-01-11
Enrollment: 171
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Measured BMI of 35.0-55.0 kg/m2 at time of screening.
2. 21- 65 years of age (inclusive) at time of screening.
3. 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).
4. Stable weight (\<3% change in self-reported weight) over the previous 3 months at time of screening).
5. 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.
6. Willing and able to provide informed consent in English and comply with the protocol.

Exclusion Criteria:

1. Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
2. Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
3. History of refractory gastric ulcers
4. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination.
5. History of radiation therapy to the chest or abdomen
6. Uncontrolled hypertension (blood pressure \>160/100).
7. Diabetes treated with insulin or sulfonylurea medications
8. Any change in diabetes medication in previous 3 months
9. Hemoglobin A1C \>9.5%
10. 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
11. Coagulation disorders (platelets \< 100,000, PT \> 2 seconds above control or INR \> 1.5)
12. Anemia (Hemoglobin \<11.0 g/dL in women and \<12.5 g/dL in men)
13. Liver enzymes (ALT and AST) ≥3.0 times the upper limit of normal
14. Thyroid Stimulating Hormone (TSH) \>1.5 x upper limit of normal at screening.
15. Osteoporosis (DEXA T-Score ≤ -2.5 standard deviations below normal peak values).
16. History of fragility fractures (fractures resulting from a fall from a standing height or less, or presenting in the absence of obvious trauma)
17. Pregnant or lactating
18. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)
19. Night Eating Syndrome (diagnosed by EDE)
20. Serum potassium \< 3.8 mEq/L
21. Chronic abdominal pain that would potentially complicate the management of the device
22. Taking a GLP-1 agonist \< 6 months.
23. 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.
24. Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
25. Self- reported history of substance abuse in last 3 years.
26. Malignancy in the last 5 years (except for non-melanoma skin cancer).
27. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy.
28. 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).

Primary outcomes:
measure: Mean Percent Excess Weight Loss (%EWL)
timeFrame: 52 weeks
measure: % of Subjects Who Achieve >25% EWL
timeFrame: 52 weeks
Secondary outcomes:
measure: Mean Percent Total Body Weight Loss
timeFrame: 52 weeks
measure: Percent of Subjects With ≥10% Total Body Weight Loss
timeFrame: 52 weeks
measure: Mean Percent Change in Serum Lipids
timeFrame: 52 weeks
measure: Mean Percent Change in Blood Pressure
timeFrame: 52 weeks
measure: Mean Change in Score for IWQOL Questionnaire
timeFrame: 52 weeks
measure: Mean Change in Hemoglobin A1C
timeFrame: 52 weeks
measure: Procedural Success
timeFrame: 52 weeks
measure: Change in Medication for Hypertension
timeFrame: 52 weeks
measure: Change in Medications for Dyslipidemia
timeFrame: 52 weeks
measure: Change in Medications for Type 2 Diabetes
timeFrame: 52 weeks
measure: Change in Number of Subjects on Hypertension Medication
timeFrame: 52 weeks
measure: Change in Number of Subjects on Dyslipidemia Medications
timeFrame: 52 weeks
measure: Change in Number of Subjects on Diabetes Medication
timeFrame: 52 weeks
Other outcomes:
measure: Safety Outcomes
timeFrame: 52 weeks
Locations:
city: San Diego
country: United States
facility: Dept VA San Diego Health Care System
state: California
city: Washington
country: United States
facility: Howard University Center for Wellness and Weight Loss Surgery
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher Thompson, MS, MD
role: PRINCIPAL_INVESTIGATOR
References: