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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34180
Enrollment
15
Registered
2011-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastro-oesophageal reflux disease reflux

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To correlate tissue impedance, expressed in Ohm, and degree of dilation of intercellular spaces with electron microscopy.

Secondary

MeasureTime frame
Not applicable.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)