ISRCTN81340421已完成未知
A multicenter study to investigate the efficacy and safety of the Satisphere™ duodenal insert in overweight patients
Endosphere Inc (USA)0 个研究点目标入组 60 人开始时间: 2012年10月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
A multicentre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair lossCancerISRCTN00283877eiden University Medical Centre (LUMC) (The Netherlands)260
已完成
不适用
A Safe and Non-invasive Breast Cancer Screening SolutioCTRI/2017/10/010115IRAMAI Health Analytix Pvt Ltd258
已完成
2 期
Multi-center study to evaluate the efficacy and to standardize RFA for early breast cancerEarly breast cancerJPRN-UMIN000008675ational Cancer Center Hospital372
已完成
不适用
A multicenter prospective study on the efficacy and safety of denosumab in gastrointestinal cancer patients receiving short-term periodic steroid premedication of chemotherapy-induced nausea and vomiting (ESPRESSO-02/HGCSG1602)Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)JPRN-UMIN000023855HGCSG (Hokkaido Gastrointestinal Cancer Study Group)45
尚未招募
不适用
Multidomain Intervention Via a None-face-to-face Platform in Mild Cognitive ImpairmentMental and behavioural disordersKCT0007184Inha University Hospital100