Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in liver histology
研究概览
简要总结
The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).
详细描述
The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for weight reduction in obese patients. This study will determine the feasibility of using BIB in the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the efficacy of the BIB in improving histology of NASH in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Patients between 21-65 years of age,
- •Had histological evidence of NASH,
- •Had a BMI of greater than 27kg/m2, and
- •Had failed at least 6 month trial of medical therapy for weight reduction.
排除标准
- •Patients with any organic disease of the upper GI tract,
- •Were receiving anti-inflammatory drugs,
- •Anticoagulants or steroids, or
- •Had a history of alcoholism or drug addiction. A hiatus hernia of > 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of BIB.
结局指标
主要结局
Change in liver histology
时间窗: 6 months
The primary outcome measure was liver histology before and after treatment. Assessment of disease activity was done with the use of the NAS, which grades steatosis, lobular inflammation and hepatocellular ballooning.
次要结局
未报告次要终点