NCT03472196已完成不适用
First in Human Clinical Study to Assess the Safety and Preliminary Performance of NitiNotes' Endoluminal Gastroplasty System (EndoZip) for the Treatment of Obesity
Nitinotes Surgical Ltd.2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年3月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Primary - Serious Adverse Events
研究概览
简要总结
This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, male or female, is age 18 to 60 years of age.
- •Subject must be able to understand and be willing to sign an informed consent form.
- •Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
- •Subject has a BMI of 30-40 kg/m2
- •Have had no significant weight change (±5% of total body weight) during 6 months prior to enrollment
- •Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
- •Subject must be of sufficient and stable medical and mental health, as evaluated by the Principal Investigator.
- •Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
- •Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination.
- •Subject agrees not to have any additional weight loss interventional procedures, such as mammoplasty or abdominal lipoplasty or liposuction, or take any over the counter or prescription weight loss medication for the entire study participation duration
- •Type II Diabetes patients who are treated with oral glucose lowering agent and are stable are acceptable.
排除标准
- •Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
- •Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
- •Uncontrolled diabetes or change in diabetes medication and/or dosage in the 3 months prior to enrolment
- •Uncontrolled hypertension
- •Subject with heart failure, NYHA grade 2 and above.
- •Subject has pre-existing respiratory disease, such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- •Subject has significant esophageal disease including Zenker's diverticulum, severe gastro-esophageal reflux disease (GERD), stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility, which is not controlled with medication.
- •Subject has renal and/or hepatic insufficiency/disease (creatinine above 1.5 mg/dL)
- •Subject has thyroid disease, which is not controlled with medication.
- •Subject is diagnosed with ostocorticular pain, pre-neoplastic lesions or coagulation conditions that may prevent him/her from undergoing a surgical procedure.
- •Subject has a history of intestinal strictures or adhesions and/or any condition that could preclude passage of endoluminal instruments.
- •Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device use), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- •Subject is diagnosed with a coagulation disorder.
- •Subjects undergoing chronic steroid therapy.
- •Subjects undergoing immunosuppressive therapy.
- •Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
- •Subjects who have known hiatal hernias greater than 5 cm.
- •Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
- •Subject has active Crohn's disease or Colitis.
- •Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
- •Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within 6 months prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study and their participation may interfere with the current study.
- •Subject has any condition that, at the discretion of the investigator, would preclude participation in the study.
- •Unstable diabetes patients who are treated with insulin.
结局指标
主要结局
Primary - Serious Adverse Events
时间窗: 6 months
Incidence of device related SAEs within 6 months post procedure
次要结局
- Efficacy - Suture Durability(6 months)
- Efficacy - % Excess Weight Loss (EWL)(6 months)
研究者
研究点 (2)
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