ISRCTN41367345已完成不适用
An evaluation of the Medtronic Gatekeeper system in the treatment of subjects with gastro-oesophageal reflux disease (GERD)
Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 144 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
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. Subjects must be at least 18 years of age
- •2. Subjects with documented typical symptoms of GERD
- •3. Female subjects of child bearing potential must have a negative pregnancy test within 1 week before treatment and must agree to use an effective means of birth control during participation in the study
- •4. Subjects who show symptomatic improvement on PPI and want to discontinue their GERD medication
- •5. Subjects who have demonstrated a baseline 24 hour ph greater than 4% time with pH less than 4.0
- •6. Subjects with a baseline GERD-HRQL heartburn score of less than 11 on PPI and greater than 20 off PPI
- •7. Subjects who have been informed of the nature of the study and have agreed to its provisions and provided ICF, approved by the Institutional Review Board or Medical Ethics Committee of the respective clinical site
排除标准
- •1. Classified in anaesthesia risk group, American Society of Anaesthesiologists (ASA) class III - IV
- •2. Extensive barret's oesophagus (greater than 2 cm)
- •3. Oesophagitis (grades III - IV)
- •4. Complaints of dysphagia
- •5. Oesophageal strictures
- •6. Oesophageal or gastric varices
- •7. Previous history of gastro-oesophageal surgery, anti-reflux procedures, or gastro-oesophageal or gastric cancer
- •8. Large hiatal hernia (greater than 3 cm)
- •9. Ineffective oesophageal motility, defined as amplitudes of less than 30 mmHg greater than 50% of the time
- •10. Diagnosed with morbid obesity (body mass index [BMI] greater than 35 kg/m^2)
- •11. Immunocompromised subjects (subjects diagnosed with human immunodeficiency virus (HIV), on chronic steroid use or other immunosuppressants, such as Immuran)
- •12. History of bleeding diathesis or coagulopathy or who will refuse blood transfusions
- •13. Inability to discontinue anticoagulation therapy
- •14. Suffered a stroke or transient ischemic neurological attack (TIA) within the past 6 months
- •15. Experienced a haematologically significant gastrointestinal bleed within the past 6 months
- •16. Has other medical illness that may cause the subject to be non-compliant with or unable to meet the requirements of the protocol or is associated with limited life expectancy
- •17. Simultaneously participating in another device or drug study, or who has participated in any clinical trial involving an experimental device within 6 months or experimental drug within 30 days of study entry
- •18. Unable or unwilling to cooperate with study procedures
研究者
相似试验
已完成
不适用
An evaluation of the Medtronic Gatekeeper system in the treatment of subjects with Gastroesophageal reflux disease (GERD).GERDNL-OMON29549Medtronic Gastroenterology/Urology4000 Lexington Avenue NorthShreview, MN 55126-3755144
已完成
不适用
Evaluation of minimally invasive monitoring system for postprandial hyperglycemiaJPRN-UMIN000004274Osaka University School of Medicine50
招募中
2 期
Evaluation of the effect of digital monitoring system on surgical successIRCT20220304054177N1Iran University of Medical Sciences216
已完成
不适用
Evaluation of minimal invasive monitoring system for postprandial hyperglycemiaType 2 diabetesJPRN-UMIN000007355Kobe University50
已完成
不适用
Evaluation of minimal invasive monitoring system for postprandial hyperglycemiaType 2 diabetesJPRN-UMIN000003761Osaka Medical Center for Cancer and Cardiovascular Diseases10