A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
研究概览
简要总结
This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.
详细描述
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
This study will be conducted at a single clinical site in Malaysia. Approximately 16 subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted one week apart with the implantation of the second cohort triggered by the absence of major technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the first seven days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 21 years and < 65 years - male or female
- •Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
- •Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
- •Glycemic state: HbA1c at screening 7.0-10.0%.
- •History of failure with non-surgical weight loss methods
- •Subjects willing to comply with study requirements
- •Subjects who have signed an informed consent form
排除标准
- •Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)
- •Subjects requiring anticoagulation therapy
- •Subjects with iron deficiency and iron deficiency anemia
- •Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
- •Treatment represents an unreasonable risk to the subject
- •Known history of acute or chronic pancreatitis
- •Known history of organ failure (i.e. renal insufficiency, heart failure, fibrotic / cirrhotic liver disease, or pulmonary disease)
- •Symptomatic coronary artery disease or pulmonary dysfunction
- •Subjects with known symptomatic biliary disease
- •Known infection at the time of implant
- •Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- •Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- •Pregnant or has the intention of becoming pregnant in the next 6 months
- •Unresolved alcohol or drug addiction
- •HIV positive subjects
- •Subjects with hepatitis B or C
- •Currently taking the following medications within 30 days of implant:
- •systemic corticosteroids, drugs known to affect GI motility, prescription or over the counter weight loss medications such as Sibutramine hydrochloride monohydrate and Orlistat
- •Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
- •Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement in this clinical trial
- •Previous GI surgery that could affect the ability to place the liner or the function of the implant.
- •Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- •H. pylori positive subjects (Note: patients may be enrolled if they had a prior history and were successfully treated).
- •Family or subject history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •Unable to tolerate proton pump inhibitors
- •Participating in another ongoing investigational clinical trial that is ongoing or within 3 months of the implant date
- •Positive stool guaiac at time of screening
结局指标
主要结局
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
时间窗: 3 months
Safety will be evaluated as the incidence of AEs and SAEs/UADEs.
次要结局
- Efficacy as measured by Change in HbA1c (%)(3 months)
- Efficacy as measured by Change in Body weight(3 months)
- Efficacy as measured by Percent excess weight loss(3 months)