NCT04773795已完成不适用
Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods
Nitinotes Surgical Ltd.2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年6月30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
- 48
- 试验地点
- 2
- 主要终点
- Change in Body Total Body Weight Loss (kg) From Baseline to12 Months
研究概览
简要总结
A multicenter, prospective, single-arm, open-label, controlled clinical trial aimed to evaluate the safety and effectiveness of the EndoZip system procedure, coupled with lifestyle modifications, for weight reduction in obese patients with BMI of 30-40 kg/m2.
详细描述
study will include up to 45 (10-20 patients per site), ages of 21 -70 of obese patients who failed to reduce weight with non-surgical weight-loss methods.
The duration for each participant will be 12 months and will include the following follow up visits and procedures:
- Office visits: screening, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s)
- Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s)
- Endoscopy procedure: baseline, 2 and 6 months post EndoZip procedure
- Motility evaluation by Gastric Emptying Breath Test (GEBT): baseline, 6 months
- Physical examination, vital signs, waist circumference and BMI: baseline, 1 week, 1, 2, 4, 6, 8, 10 and 12 months
- Blood tests: baseline,2, 6 and 12 months
- IWQOL-Lite: baseline, 2, 6 and 12 months
- Psychological health questionnaire-9 (PHQ-9) :baseline
- Sleep Apnea (only for the relevant population): baseline 2, 6 and 12 months
The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 30 and ≤40 kg/m².
- •Willingness to comply with the substantial behavioral modifications program as required by the procedure.
- •Patients with history of failure with non-surgical weight-loss methods.
- •Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing IWQOL questionnaire and completing the medically supervised diet and behavior modification program.
- •Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.
- •Ability to give informed consent.
- •Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
排除标准
- •Prior surgery of any kind on the gastrointestinal tract (except uncomplicated cholecystectomy or appendectomy).
- •Patients with history of small bowel or colonic obstruction, and/or adhesive peritonitis and/or abdominal adhesions.
- •Patients with any inflammatory disease
- •Patients with history of cancer in the gastrointestinal tract.
- •Potential upper gastrointestinal bleeding conditions such as a history of angioectasias.
- •A known gastric mass or gastric polyps > 1 cm in size.
- •Patients with TG >500 or LDL >190
- •A known hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy.
- •A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
- •Patient with motility disorders of the GI tract or intractable constipation
- •Patients with known coagulation disorder (INR >1.5) or on anticoagulation therapy.
- •Type 1 diabetes or Type 2 diabetes with a HgbA1c >8 in 6 weeks prior the procedure or use of any medication for diabetes other than metformin. Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
- •Patients with chronic abdominal pain
- •Patients with hepatic insufficiency or cirrhosis
- •Patients that used an intragastric device for weight loss within 2 years prior to this study.
- •Patients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher.
- •Patients receiving daily prescribed treatment with high dose aspirin (> 100mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
- •Patients with history or current abuse of drugs or alcohol
- •Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
- •egg, milk, or wheat allergy (unable to go through the GEBT)
- •Patients who are pregnant or breast-feeding.
- •Patients who are taking medications that cause weight loss
- •Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 12 months, poorly-controlled hypertension, required use of NSAIDs
- •Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
- •Patients who are taking corticosteroids, immunosuppressants, and narcotics
- •Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- •Pre-existing respiratory disease such as chronic obstructive pulmonary disease (severe COPD), pneumonia or cancer.
- •Diagnosis of autoimmune connective tissue disorder (e.g. lupus, HIV, erythematous, scleroderma) or immunocompromised.
- •Specific diagnosed genetic disorder such as Prader Willi syndrome (motility disorder)
- •Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
- •Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
结局指标
主要结局
Change in Body Total Body Weight Loss (kg) From Baseline to12 Months
时间窗: 12 month
Change in body total body weight loss (kg) from baseline to 12 months post EndoZip procedure
Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months.
时间窗: 12 month
Percentage of patients with a reduction in %TBWL of at least 5% from baseline to 12 months.
次要结局
未报告次要终点
研究者
研究点 (2)
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