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临床试验/ACTRN12618001888257
ACTRN12618001888257尚未招募未知

Endoscopic Sleeve Gastroplasty (ESG) for obesity complicated by non­-alcoholic steato­hepatitis (NASH) +/­ type  two diabetes mellitus: A feasibility study.

Dr Damian Harding (Chief researcher)0 个研究点目标入组 10 人开始时间: 2018年11月20日最近更新:
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适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
10
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 65 Years（—）
性别
All

入选标准

  • •Obesity (body mass index) of greater than or equal to 35kg/m2, and up to 45kg/m2.
  • •Diagnosis of non-alcoholic steato-hepatitis (NASH) based on liver biopsy.

排除标准

  • •-Cirrhosis
  • •-Significant alcohol consumption (>20g/day females, >30g/day males)
  • •-Other causes of liver disease (untreated viral hepatitis, auto-immune hepatitis)
  • •-Other significant medical morbidity associated with a poor long term prognosis or high pre-procedural risk. (This includes a history of previous unprovoked deep vein thrombosis or pulmonary embolism.)
  • •-Anti-coagulation
  • •-Use of medications that may affect the natural history of NAFLD/ NASH (obeticholic acid, pioglitazone, incretin mimetics, such as liraglutide; SGLT-2 inhibitors).
  • •-History of previous gastric or oesophageal surgery, gastric ulcer, hiatus hernia >5cm.
  • •-Pregnancy. (Where applicable) female subjects should avoid pregnancy pre-operatively and for 12 to 18 months post-operatively.
  • •-Current active psychiatric illness, substance abuse or dependence.
  • •-Presence of chronic, un-evaluated abdominal pain symptoms.
  • •-Unwilling to consent to study requirements for monitoring and follow up.

研究者

发起方
Dr Damian Harding (Chief researcher)

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