ISRCTN98465849进行中（未招募）未知
Assessing weight loss, adverse events, and resolution of comorbid conditions associated with the use of the BariClip device in adult patients with severe obesity in Jordan
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Age 18 – 65 years
- •2. Male or female
- •3. BMI >40 kg/m² and BMI >30 kg/m² with at least one comorbid condition (hypertension [HTN], type 2 diabetes [DT2], sleep apnea)
- •4. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure (written consent form)
- •5. History of obesity for at least 5 years
- •6. History of failure with dieting methods
- •7. Willingness to follow protocol requirements including signed consent, routine follow-up schedule, completing quality of life (QOL) questionnaires, completing laboratory tests, completing diet and behavior modification counseling
- •8. Residing within a reasonable distance from an investigating center and able to travel to the investigator to complete all routine follow-up visits
排除标准
- •1. Surgery or treatment represents an unreasonable risk to the subject
- •2. Patient history of inflammatory disease of the gastrointestinal (GI) tract (including ulceration, duodenal ulceration, grade 4 esophagitis, specific inflammation such as Crohn’s disease or ulcerative colitis)
- •3. Severe cardiopulmonary disease or other serious organic disease
- •4. Severe coagulopathy, upper gastrointestinal (UGI) bleeding conditions, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- •5. Congenital or acquired anomalies of the GI
- •6. Severe hiatal hernia (>3 cm)
- •7. Pregnant or has the intention of becoming pregnant in the next 12 months
- •8. Alcohol or drug addiction, active smoker
- •9. Mental retardation or emotional instability, or psychological characteristics which, in the opinion of the investigators, make the subject a poor candidate for clip surgery
- •10. Previous esophageal, gastric surgery, hepatectomy, splenectomy
- •11. Previous endoscopic procedure for obesity
- •12. Patient under GLP1 medication or weight loss drug
- •13. Diabetes patient under treatment for gastroparesis
- •14. Previous bariatric surgery, intestinal obstruction, or adhesive peritonitis
- •15. Patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder
- •16. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the Clip clinical trial
研究者
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