NL-OMON37296尚未招募不适用
INX* Reflux Management System Clinical Study - LINX* Reflux Management System Clinical Study
Torax medical, Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age * 19 years - * 75 years
- •Suitable surgical candidate
- •Patient requires daily PPI or other anti-reflux therapy
- •Total distal Ambulatory Esophageal pH must be * 4.5% of the time * pH4
- •GERD symptoms in absence of anti-reflux therapy
- •Subject has signed an ICF
排除标准
- •The procedure is an emergency procedure
- •Patient is currently being treated with another investigational drug or investigational device
- •Prior gastric esophageal surgery
- •Any previous endoscopic anti-reflux intervention for GERD and /or previous endoscopic intervention for treatment of Barret's esophagus
- •Suspected or confirmed esophageal or gastric cancer
- •Hiatal hernia > 3 cm
- •Esophageal motility less than 35 mmHg peristaltic amplitude on wet swallows or < 70% (propulsive) peristaltic sequences
- •Esophagitis grade C-D
- •Symptoms of dysphagia more than once a week within the last 3 months
- •Patient diagnosed with scleroderma or achalasia, Nutcracker esophagus
- •Gross esophageal anatomic abnormalities or esophgeal stricture
- •Patient is pregnant or nursing or plans to become pregnant
- •Patient has Barret esophagus
- •Allergies to titanium, stainless steel, nickel or ferrous materials
- •Diagnosed psychiatric disorders
研究者
相似试验
已完成
不适用
LINX Reflux Management System Clinical Study ProtocolGastroesophageal RefluxNCT00776997Torax Medical Incorporated100
已完成
不适用
A Post-Approval Study of the LINX® Reflux Management SystemGastroesophageal Reflux Disease (GERD)NCT01940185Torax Medical Incorporated200
尚未招募
Unknown
To find how much of food gets refluxed into food pipe from stomach using a 24 hour pH study in patients undergoing keyhole surgery using angle of His accentuation technique for patients suffering from Achalasia CardiaCTRI/2024/03/064771ALL INDIA INSTITUTE OF MEDICAL SCIENCES
撤回
不适用
Ambulatory 24-h reflux monitoring: a comparison between glass-, antimony- and ISFET electrodesGORDheartburn10017943NL-OMON32064niversitair Medisch Centrum Utrecht23
已完成
不适用
Ambulatory 24-h reflux monitoring: a comparison between glass-, antimony- and ISFET electrodesGORDheartburn10017943NL-OMON32307niversitair Medisch Centrum Utrecht23