Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study


NCT ID: NCT01766037
Sponsor Protocol Number: P012-001V

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

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