Aspiration Therapy for treatment of obesity with AspireAssist™ Aspiration Therapy System

Completed

• Conditions: Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN49958132
• Lead Sponsor: MINA Medical (Sweden)

Brief Summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25268305 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/28035287 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29388050

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-13
• Last Update Posted: 26 February 2018
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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 < 100,000, PT > 2 seconds above control or INR > 1.5)
10. Anemia (hemoglobin <11.0 g/dL in women and <12.5 g/dL in men)
11. Pregnant or lactating
12. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy
13. 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 (serum creatinine > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dependent variable is: weight reduction<br>Independent variables are: <br>1. Diagnosis according to ICD10 for coexisting conditions<br>2. Voiding frequency<br>3. Acute phase protein<br>4. EQ-5D<br>5. Age, gender, mass/BMI at the start of the study<br>6. ASA class

Secondary Outcome Measures

Name	Time	Method
The dependent variable is: quality of life index, as the EQ-5D <br>Independent variables are: weight gain, age, gender<br><br>1. Blood samples: 0, 4, 8, 12, 16, 30, 43 and 56 weeks <br>2. Urine samples: 0, 16, 30, 43 and 56 weeks <br>3. Bioelectric Impedance: 0, 16, 30 and 56 weeks <br>4. Quality of Life, EQ-5D (VAS): 0, 8, 30 and 56 weeks <br>5. Cognitive Behavioral Therapy (Lifestyle Therapy): Personal (2 sessions) and in Groups (6 sessions)