Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Pathological changes
研究概览
简要总结
Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways and is a complex regulator of food intake as well as lipid and glucose metabolism. This study aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization (GMD) for the management of obesity and its related comorbidities.
详细描述
Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult population that would benefit from therapy for obesity but are not receiving it. Endoscopic approaches to obesity have the potential to be more efficacious than antiobesity medications and have a lower risk-cost profile compared with bariatric surgery.
Endoscopic approaches to obesity need to be increasingly modeled on the proposed mechanisms contributing to the benefits of bariatric surgery.
The investigators seek to decipher if the gastric mucosa is an independent regulator of food intake, body weight, lipid and glucose metabolism and serum gut hormones. The investigators also wish to ascertain if selective devitalization of the gastric mucosa, without alteration in gastric volume, will improve obesity related comorbidities.
This study will be divided into 3 parts. The purpose of completing the 3 phases is to develop a minimally invasive weight loss technique that is effective, safe and ready for more rigorous assessment via a future randomized control trial.
Objectives:
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
- 28 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo vertical sleeve gastrectomy
排除标准
- •Age under 28 or older than 60
- •Insulin dependent Diabetes Mellitus
- •Suspected or biopsy confirmed liver cirrhosis
- •Significant ethanol consumption >21 drinks/week in men and >14 drinks/week in women
- •Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
- •Pregnant or breast-feeding
- •Patients who already have an intragastric balloon or other gastric implant
- •Patients with gastroesophageal reflux disease
- •Patients with previous gastric surgeries, altered gastrointestinal anatomy such as Billroth I, Billroth II, roux-en-y gastrectomy, roux-en-y hepaticojejunostomy, or any restrictive or bypass bariatric surgery
- •Patients with previous gastric embolization for obesity
- •Presence of inflammatory disorder of the gastrointestinal tract
- •Patients with active peptic ulcer disease
- •Patients with gastroesophageal varices
- •Presence of a large hiatal hernia (grade IV on Hills classification: large hiatal hernia and essentially no fold approximating the endoscope in the retroflexed view and where the lumen of the esophagus is gaping open allowing the squamous epithelium to be seen)
- •Structural abnormality in the esophagus or pharynx
- •Have major esophageal motility disorders as per the Chicago classification including achalasia, diffuse esophageal spasm, jackhammer esophagus, and Esophagogastric junction outflow obstruction
- •Mucosal or submucosal gastric mass that is clinically suspected to be of malignant nature
- •Severe clotting or bleeding disorder
- •Other medical condition that does not allow for endoscopic procedure
- •Severe psychiatric illness
- •Unable to participate in routine medical follow-up
- •On antiplatelet agents including clopidogrel, ticlopidine, prasugrel, and cangrelor. acetylsalicylic acid use will be allowed
- •On anticoagulants including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban
结局指标
主要结局
Pathological changes
时间窗: 6 months
Histopathological assessment to determine whether selective devitalization of mucosa and submucosa corresponds with decolorization during the in-vivo procedure.
次要结局
- Procedural tolerability(6 months)
- Technical feasibility(6 months)