Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Endoscopic treatment with a new device (Satisphere)
Sixty patients will be enrolled in 2 sites, twenty of whom will be randomized to a ?diet-only? control group.
Recruitment is expected to start in
Sponsors
Endosphere Inc (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18-60 years 2. Men or non-pregnant women (only women who are post-menopausal, surgically sterile or practicing a reliable contraception such as: 2.1. Hormonal [oral] contraception 2.2. Intrauterine device 2.3. Condom 2.4. Diaphragm 3. BMIs between 30 and 50 4. Patients who are healthy as determined by pre-study medical history, physical examination, 12 lead-ECG 5. Patients who are able to understand the protocol 6. Patients who have been informed of the nature of the study and have agreed to its provisions and given written informed consent as approved by the Local Research Ethics Committee or the physician of the respective clinical site
Exclusion criteria
Exclusion criteria: 1. Classified in anesthesia risk group, ASA Class 4-5 2. Crohn?s disease or Ulcerative Colitis (inflammatory bowel disease) 3. Endocrine or other disorders that can cause obesity 4. Pregnancy (a urinary test for pregnancy must be performed in female patients before inclusion in the study) 5. Women who may be attempting to become pregnant 6. Type 2 diabetes defined as fasting plasma glucose (FPG) level of >126 mg/dL and a HbA1c level > 6.5% (or at least 1 percent above the reference laboratory's upper range of normal). NB: the presence of hyperlipidemia (hypercholesterolemia, hypertrigyliceridemia) is not an exclusion criterion) 7. Present alcohol or drug abuse or a smoker 8. Previous bariatric (including lap-band) or gastrointestinal surgery 9. History of bleeding diathesis or coagulopathy or will refuse blood transfusions; 10. Patients at need of anticoagulation therapy, Aspirin, Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), or steroids 11. Experienced a hematologically significant gastrointestinal (GI) bleed within the past six months 12. Has other medical illness (i.e., congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than one year) 13. Simultaneously participating in another device or drug study, or who has participated in any clinical trial involving an experimental device within 6 months or experimental drug or device within 30 days of study entry 14. Significant depression or borderline personality disorder as indicated by medical record and/or clinical interview 15. Active suicide ideation and/or History of multiple suicide attempts within the past 5 years 16. Active psychosis present (current evidence of active psychosis and/or mental health hospitalization for psychosis in past 1 year) 17. Patients known to be binge eaters or with other eating disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excess weight loss (EWL) after 3 months of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of overweight patients who achieve a 10% or greater excess weight loss (EWL) after 3 months of therapy 2. Total weight (kg) loss after 3 months of therapy 3. Frequency and severity of all (serious and non-serious) device/procedure related adverse events over 3 months 4. Frequency and severity of all non-device/non-procedure related adverse events over 3 months 5. Tolerance of the SatiSphereTM Duodenal Insert, indicated by premature removal of the SatiSphere due to excess nausea or pain 6. Frequency of migration of the SatiSphereTM Duodenal Insert between 72 hours and 3 months post insertion 7. Effect on tissue health of the SatiSphereTM Duodenal Insert over a 3 month period | — |
Countries
Germany
Outcome results
None listed