Prospective, Single Center, Open-labeled Single Arm Study, to Asses the Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss in Healthy Over Weight and Obese Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- the change in subjects' weight presented as percent total body loss (%TBL)
研究概览
简要总结
Study design to demonstrate the safety and performance of the Epitomee Device
详细描述
Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.
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
- •21 ≤ Age <65 years
- •28 < BMI ≤ 40 kg/m2
- •Healthy subject
- •Normal blood count and chemistry
- •Subject is able and willing to give informed consent
- •Subject is able and willing to participate in the study and follow protocol procedures
排除标准
- •A. General health and medication
- •Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results
- •Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion
- •Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion
- •Taking thyroid hormone deficiency drugs (such as L-thyroxine)
- •Hemoglobin level under 11 gm/dl
- •B. Weight loss history and status
- •Currently using pharmaceutical agents or food supplements for weight loss
- •History of weight reduction of more than 5% of total body weight in the past 6 months
- •Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating*
- •C. Specific GI history and status
- •History or evidence of any active liver disease. (abnormal liver functions: >1.5 times upper limit)
- •Subject with Inflammatory Bowel Disease (IBD)
- •Significant swallowing disorders
- •Less than 3 natural bowel movements per week
- •Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)
- •Malabsorption disorders
- •History of food allergy according to PI decision
- •Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study
- •History of alcohol or drug abuse within 6 months of screening
- •Mental disorders
- •Currently participating in an ongoing clinical study
研究组 & 干预措施
Epitomee Device arm
A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety. The Device is composed of a 000 size standard capsule and the Tulip's proprietary Device, encapsulated within it.
The Device components are produced from approved pharmaceutical excipients / food additives / generally recognized as safe (GRAS )/ food contact materials which are used at high grade
干预措施: Epitomee Device (Device)
结局指标
主要结局
the change in subjects' weight presented as percent total body loss (%TBL)
时间窗: Baseline, 12 weeks
Subjects loss of weight described as %TBL
Safety evaluation of the Device administration.
时间窗: Baseline, 12 weeks
Normal Gastroscopic examination as assessed by an independent safety committee.
次要结局
未报告次要终点