Tissue impedance measurement (TIM) as an index of oesophageal mucosal integrity - Tissue impedance measurement (TIM): index of oesophageal mucosal integrity

niversitair Medisch Centrum Utrecht0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•* Females and males between 18 and 45 yrs of age
•* No significant clinical pathology or history of heartburn, regurgitation, dysphagia or chest pain or acid
•suppressive therapy or any other major abdominal complaints in the last year. No history of signs of pathological
•changes of the oesophageal mucosa visible with conventional endoscopic examination
•* BMI < 30 or a body weight < 100 kg
•* No clinically significant illness within the 2 weeks prior to inclusion or a suspected/manifest infection according
•to WHO risk categories 2, 3 or 4, as judged by the investigator
•* No history of clinically significant illness, cardiovascular, respiratory, renal, hepatic, neurological, mental or
•gastrointestinal, as judged by the investigator
•* Normal ECG as judged by the investigator
•* Absence of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensivity
•* No history of excessive bleeding or suspected coagulopathy
•* No prior surgery of the upper GI tract except over sewing of an ulcer
•* No use of PPI, H2 receptor antagonists, pro-kinetic drugs or need for any medication for gastroesophageal
•reflux disease
•* No history of drug addiction (including cannabinoids), alcohol abuse or other circumstances which in the investigator*s judgment may compromise the subject*s participation
•* No involvement in the planning and conduct of the study
•* No pregnancy or lactation
•* Signed informed consent to participate in the study

•* Clinically significant illness within the 2 weeks prior to inclusion or a suspected/manifest infection according to
•WHO risk categories 2, 3 or 4, as judged by the investigator
•* Absence of informed consent
•* BMI *30 or a body weight * 100 kg
•* History of clinically significant illness, cardiovascular, respiratory, renal, hepatic, neurological, mental or
•gastrointestinal, as judged by the investigator
•* Abnormal ECG as judged by the investigator
•* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensivity
•* History of excessive bleeding or suspected coagulopathy
•* Prior surgery of the upper GI tract except over sewing of an ulcer
•* Use of PPI, H2 receptor antagonists, pro-kinetic drugs or need for any medication for gastroesophageal reflux
•* History of drug addiction (including cannabinoids), alcohol abuse or other circumstances which in the
•investigator*s judgment may compromise the subject*s participation
•* Inability to comply with study procedures
•* Involvement in the planning and conduct of the study
•* Previous enrolment in the present study.
•* Pregnancy or lactation

发起方

niversitair Medisch Centrum Utrecht