The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

• Conditions: Motility Disorder

• Registration Number: NCT05093010
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Currently, a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited. This BSGM provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency, amplitude, velocity, and pattern, in high spatiotemporal detail. The system is also capable of providing a novel meal response metric, which might correlate with the gastric emptying time. The system includes an App for tracking patient-reported symptoms throughout the test.The aim of the present study is to assess and compare BSGM and breath-based gastric emptying parameters and to study the relation between BSGM and presence or severity of individual symptoms and clinical features.The investigators will perform a study in 100 subjects to record gastric bioelectrical activity by non-invasive multi-channel body-surface electrode arrays during gastric emptying breathing test.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Status Verified: 2021-10
• Study Start: 2021-10
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged >18 years old;
• Male or female patients;
• Patients planned GEBT;
• Negative PCR on nasopharyngeal swab 24 or 48 hours prior to the test;
• Signed informed consent.

Exclusion Criteria

• Females who are pregnant or lactating.
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
• Fragile skin vulnerable to skin tears.
• Damaged epigastric skin (open wounds, rash, inflammation)
• Patients unable to remain in a relaxed reclined position for the test duration

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of body surface gastric mapping for delayed gastric emptying	30 minutes before the meal and 4 hours after having meal.	The correlation of electrogastrography abnormality (in percentage) and delayed gastric emptying (t 1/2, minutes) will be determined employing a regression method.

Secondary Outcome Measures

Name	Time	Method
To assess correlation between electrogastrography abnormality and upper gastrointestinal symptoms.	30 minutes before the meal and 4 hours after having meal.	Visual analogue scale (VAS) score for gastrointestinal symptoms, including pain, nausea, vomiting, bloating and flatulence will be recoded during recording gastric electrophysiological activity. The correlation of electrogastrography abnormality (in percentage) and upper gastrointestinal symptoms severity will be determined employing a regression method.