Single Arm Study of Neurotronic Fully Endoscopic Jejunoileal Side-to-side Anastomosis for Treatment of Obesity and Type II Diabetes: The Neujia 1A Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in HbA1c
研究概览
简要总结
This prospective, multicenter, open label, single arm study will enroll subjects presenting with obesity and inadequately controlled type II diabetes (T2DM). A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
详细描述
For many obese diabetics, medical treatment and lifestyle modification fail to provide acceptable glucose levels or durable weight loss. Bariatric surgical procedures have been proven to provide better glycemic control and to improve life expectancy and quality of life. But these are invasive procedures with significant complications, and notwithstanding the strong clinical evidence and consensus guidance, less than 2% of patients who would benefit from bariatric surgery choose to undergo the invasive procedures. There is therefore a significant unmet clinical need for metabolic/bariatric therapies that result in durable improvement in glycemic control, decreased anti-diabetic medication requirements, and weight loss, with fewer and less severe complications than invasive bariatric surgery.
Human clinical data suggests that partial diversion through a side-to-side jejunoileal anastomosis results in an absolute decrease in HbA1c of 1.9 to 3.6 percentage points and a decrease in total weight of 9.6 to 14.6% at 12 months. Although these studies used other methods, they provide good evidence that the anastomosis created by Neujia should be expected to safely improve glycemic control.
A minimally invasive anastomosis device (Neujia) and endoscopic delivery system have been developed to create a side-to-side jejunoileal anastomosis. One device is deployed in the jejunum, approximately 30 to 100 cm distal to the ligament of Treitz, and the other in the ileum, approximately 30 to 100 cm proximal to the ileocecal valve. The devices are mated under endoscopic guidance with fluoroscopic visualization and create a compression anastomosis. Neujia has the potential to provide a fully endoscopic, incisionless procedure that achieves durable weight loss and glycemic control without the risks of bariatric surgery. The proposed single arm study is designed to assess the feasibility and safety and efficacy of the Neujia device when used to treat T2DM and obesity. Subjects are followed for 12 months and annually thereafter for up to 5 years to assess change in metabolic parameters, medications, weight, and adverse events.
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
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 22 and < 65 years, estimated life expectancy ≥ 2 years;
- •BMI ≥ 30 and < 40 kg/m2;
- •HbA1c ≥ 8.0 and ≤ 11%;
- •Fasting Glucose (FG) ≥ 126 mg/dL;
- •Under active medical care with ≥ 6-months treatment on ≥ 2 anti-diabetic medications;
- •T2DM diagnosed ≤ 10 years prior to enrollment;
- •Non-fasting random or stimulated C-peptide ≥ 2 ng/mL (660 pmol/l);
- •Willing and able to provide informed consent, comply, and be geographically stable
排除标准
- •Type I diabetes, positive autoantibodies to glutamic acid decarboxylase 65 (GAD65), secondary diabetes;
- •Hypoglycemia unawareness or serious hypoglycemia with loss of consciousness or confusion sufficient to prevent self-treatment in last 6 months;
- •Any condition for which endoscopy or colonoscopy would be contraindicated;
- •Any condition for which general anesthesia would be contraindicated;
- •Congenital or acquired anomalies of the gastrointestinal (GI) tract, abnormal GI anatomical finding, or anatomy precluding deep small bowel enteroscopy sufficient to prevent endoscopic advancement to the target treatment site;
- •Previous laparoscopic or open abdominal or pelvic surgery (except for prior caesarian section or laparoscopic cholecystectomy, which are allowed);
- •History of abdominal or pelvic infection or disease or procedures that may have resulted in abdominal adhesions;
- •Known history of autoimmune bowel disease or chronic inflammatory bowel disease (IBD);
- •Active inflammatory gastrointestinal disease (e.g., pancreatitis, hepatitis) or systemic infection (e.g., tuberculosis, malaria);
- •Known history of chronic liver disease (except nonalcoholic steatohepatitis (NASH)/ nonalcoholic fatty liver disease (NAFLD)), hepatic cirrhosis, or current transaminase/alkaline phosphatase elevation above three times the upper limit of normal (in the absence of NASH/NAFLD);
- •Severe or unstable pulmonary or circulatory comorbidities posing risks to the patient that may confound the results of the study in investigator's judgment;
- •History of cardiovascular event within last 6 months or with chronic sequela;
- •Uncontrolled hypertension with systolic blood pressure (SBP) over 160 mmHg or diastolic blood pressure (DBP) over 110 mmHg;
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min per 1.73 m2;
- •Currently taking pre-meal, bolus, or premixed insulin (patients on basal insulin only are allowed);
- •Malignancy that required therapy in the last 5 years (unless cancer only in situ e.g. basal cell carcinoma (BCC)), history of organ transplantation, or currently on immune-suppressive, chemotherapeutic, or radiation therapy;
- •History of vasculopathy, coagulopathy, or currently on anti-coagulation therapy;
- •Abnormal wound healing, e.g., human immunodeficiency virus (HIV), corticosteroid, or immunosuppressive agent use;
- •Planned magnetic resonance imaging (MRI) or any condition for which MRI is likely to be indicated within 3 months;
- •Pregnant or planning on becoming pregnant within 12 months of procedure;\
- •Known serious or uncontrolled psychiatric disease, eating disorder, or active alcohol or drug addiction.
研究组 & 干预措施
Treatment
A dual path jejunoileal side-to-side anastomosis is endoscopically created using the Neujia device.
干预措施: Neujia (Device)
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
次要结局
- Composite Safety: percent of subjects with Freedom from bowel perforation, anastomotic leak, stricture, obstruction, and prolonged dumping syndrome (>90 days)(1, 3, 6, 9, 12, 24, 36, 48, 60 months)
- Technical and Procedural Success(1 day)
- Change in HbA1c(1, 3, 6, 9, 12, 24, 36, 48, 60 months)
- Percentage with HbA1c ≤ 6.5% or ≤ 7.0%, by medication status(1, 3, 6, 9, 12, 24, 36, 48, 60 months)
- Reversal or Revision Rate(1, 3, 6, 9, 12, 24, 36, 48, 60 months)
- Change in diabetic medications(1, 3, 6, 9, 12, 24, 36, 48, 60 months)
- Change in fasting plasma glucose (FG)(1, 3, 6, 9, 12, 24, 36, 48, 60 months)
- Change in weight(1, 3, 6, 9, 12, 24, 36, 48, 60 months)