ISRCTN81340421
Completed
未知
A multicenter study to investigate the efficacy and safety of the Satisphere™ duodenal insert in overweight patients
Endosphere Inc (USA)0 sites60 target enrollmentOctober 10, 2012
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Endosphere Inc (USA)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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