Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT01766037

Run by

Aspire Bariatrics, Inc.

People needed

171

Starts

2012-11-13

Expected to finish

2019-03-30

Last updated by the study team

2020-01-27

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Dept VA San Diego Health Care System — San Diego, California, United States
• Howard University Center for Wellness and Weight Loss Surgery — Washington D.C., District of Columbia, United States
• Northwestern University — Chicago, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Weill Cornell Medical College — New York, New York, United States
• St. Mary Medical Center — Langhorne, Pennsylvania, United States
• University of Pennsylvania Center for Weight and Eating Disorders — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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