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

Withdrawn

• Conditions: gastro-oesophageal reflux disease; reflux; 10017977

• Registration Number: NL-OMON34180
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

* 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

Exclusion Criteria

* 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
disease
* 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To correlate tissue impedance, expressed in Ohm, and degree of dilation of<br /><br>intercellular spaces with electron microscopy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>