NL-OMON21950招募中不适用
Single center, prospective, single-arm feasibility study to evaluate the safety of the PlenSat Digestible Balloons in the treatment of obesity
PlenSat0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1. Subject, male or female, is age 18 to 80 years of age.
- •2. Subject must be able to understand and be willing to sign an informed consent document.
- •3. 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.
- •4. Subject has a BMI of 30 – 39.9 kg/m2.
- •5. Subject must be of sufficient and stable medical health, as evaluated by the Principal Investigator.
- •6. Subject must have a primary care physician that will manage the subject for any comorbid conditions throughout the study.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1. The subject has a history of gastro-duodenal ulcer disease and/or signs and/or symptoms of gastro-duodenal ulcer disease, which are treated with proton pump inhibitors (PPIs).
- •2. Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years.
- •3. Subject has significant oesophageal disease including Zenker’s diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett’s oesophagus, oesophageal cancer, oesophageal diverticulum, dysphagia, or achalasia.
- •4. Subject has significant signs of dysmotility of the gastrointestinal tract and/or uses prokinetic drugs/agents (domperidone, erythromycin, metoclopramide, etc.) or laxative drugs (macrogol, lactulose, etc.).
- •5. Subject uses opioid drugs and/or medications (codeine, tramadol, fentanyl, morfine,etc.) for any disease or symptoms, or has used opioid drugs/medications during the past six weeks.
- •6. Female subject is pregnant (diagnosed with a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
- •7. Subject has had previous bariatric, gastric or oesophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; oesophageal or gastric varices, or gastroparesis.
- •8. Subjects who have current or potential neck masses and/or swallowing disorders that, in the opinion of the investigator, may cause swallowing problems during the procedure.
- •9. Subject currently uses or has a history of illicit drug(s) use, or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- •10. Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within £ 28 days prior to the enrolment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study.
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