Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Added 03/05/207:
The therapy has already been the subject of three pilot studies and is also the subject of a randomized controlled trial in the US under ClinicalTrials.gov NCT01766037 with results pu
Sponsors
MINA Medical (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The AspireAssist Aspiration Therapy System is intended to provide gastric drainage for aspiration therapy to facilitate weight reduction in morbidly obese adults 25 to 65 years with a Body Mass Index (BMI) of >35 kg/m2, and must be used concurrently with a weight management support program. Patients must have failed to lose weight or maintain long-term weight loss with more conservative weight reduction alternatives, such as diet, exercise and behavior modification programs.
Exclusion criteria
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. History of radiation therapy to abdomen 5. Uncontrolled hypertension (blood pressure>160/100) 6. Diabetes treated with insulin or sulfonylurea medications 7. Hemoglobin A1C =8.5 % 8. 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 9. Coagulation disorders (platelets 2 seconds above control or INR > 1.5) 10. Anemia (hemoglobin 1.5 mg/dL, including Stage II or more severe chronic kidney disease). 14. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria) 15. Serum potassium < 3.8 mEq/L. 16. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination 17. Chronic abdominal pain that would potentially complicate the management of the device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dependent variable is: weight reduction Independent variables are: 1. Diagnosis according to ICD10 for coexisting conditions 2. Voiding frequency 3. Acute phase protein 4. EQ-5D 5. Age, gender, mass/BMI at the start of the study 6. ASA class | — |
Secondary
| Measure | Time frame |
|---|---|
| The dependent variable is: quality of life index, as the EQ-5D Independent variables are: weight gain, age, gender 1. Blood samples: 0, 4, 8, 12, 16, 30, 43 and 56 weeks 2. Urine samples: 0, 16, 30, 43 and 56 weeks 3. Bioelectric Impedance: 0, 16, 30 and 56 weeks 4. Quality of Life, EQ-5D (VAS): 0, 8, 30 and 56 weeks 5. Cognitive Behavioral Therapy (Lifestyle Therapy): Personal (2 sessions) and in Groups (6 sessions) | — |
Countries
Czech Republic, Italy, Netherlands, Spain, Sweden
Contacts
Public ContactMonica Ferrante
Outcome results
None listed