Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) to Achieve Duodeno-Ileostomy Diversion in Adults With Obesity and Type 2 Diabetes Mellitus: MAGNET 2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Magnet Placement
研究概览
简要总结
The purpose of this clinical research study is to evaluate the feasibility / performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults.
详细描述
The purpose of this clinical research study is to evaluate the feasibility/performance, safety and initial efficacy of the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable) for creation of a side-to-side anastomosis duodeno-ileostomy in obese adults. This partial diversion of intestinal contents from duodenum to the ileum is intended to facilitate weight management/loss in obese adults with type 2 diabetes mellitus (T2DM) and improve metabolic outcomes in obese adults with type 2 diabetes mellitus (T2DM). Side-by side- anastomoses are currently created by sutures, staples, and anastomotic compression devices. A predicate procedure is the single-anastomosis duodeno- ileostomy (SADI) procedure.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age, inclusive, at the time of informed consent
- •BMI 30-34.9 kg/m2
- •Type 2 Diabetes Mellitus (T2DM; defined as HbA1c 6.5%), without previous sleeve gastrectomy, and without plan to perform a concurrent sleeve gastrectomy.
- •Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for the duration of the study
- •If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study
- •Willing and able to comply with protocol requirements
排除标准
- •Type 1 diabetes
- •Use of injectable insulin
- •Uncontrolled T2DM
- •Previous sleeve gastrectomy procedure or plan to perform a sleeve gastrectomy with the duodeno-ileal anastomosis procedure
- •Uncontrolled hypertension, dyslipidemia or sleep apnea
- •Prior intestinal, colonic or duodenal surgery, other than bariatric
- •Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contra-indicate the procedure, including scarring and abnormal anatomy.
- •Refractory gastro-esophageal reflux disease (GERD)
- •Barrett's disease
- •Helicobacter pylori positive and/or active ulcer disease
- •Large hiatal hernia
- •Inflammatory bowel or colonic diverticulitis disease
- •Any anomaly precluding orogastric access by gastroscope and catheters, and manipulation techniques.
- •Implantable pacemaker or defibrillator
- •Psychiatric disorder, except well-controlled depression with medication for >6 months
- •History of substance abuse
- •Woman who is either pregnant or breast feeding
- •Woman of childbearing potential who does not agree to use an effective method of contraception.
- •Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the magnets.
- •Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target magnet deployment site
- •Expected need for MR imaging within the first 2 months after the procedure
- •Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures
- •Had surgical or interventional procedure within 30 days prior to procedure
- •Any scheduled surgical or interventional procedure planned within 30 days post- procedure
- •Any stroke/TIA within 6 months prior to consent
- •Requires chronic anticoagulation therapy (except aspirin)
- •Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure
- •Unable to comply with the follow-up schedule and assessments
- •Recent tobacco or nicotine product cessation within < 3 months prior to informed consent
- •Known allergies to the device components or contrast media
- •Limited life expectancy due to terminal disease
- •Currently participating in another clinical research study with an investigational drug or medical device
- •A positive COVID-19 test prior to the study procedure in accordance with local COVID-19 protocol
- •Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 360 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen)
研究组 & 干预措施
MAGNET System, DI Biofragmentable
GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System (MAGNET System, DI Biofragmentable)
干预措施: MAGNET System, DI Biofragmentable (Device)
结局指标
主要结局
Magnet Placement
时间窗: 1 Day (during study index procedure)
MagGJ System placement ≥ 90% alignment of magnets
Natural Magnet Passage
时间窗: Index Procedure through 90 days
Passage of magnets without surgical re-intervention
Anastomosis Patency
时间窗: Index Procedure through 90 days
Confirmed radiologically
次要结局
未报告次要终点