The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05093010

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Motility Disorder

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Relationship Between Body Surface Gastric Mapping (BSGM) and Gastric Emptying Rate

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT05093010

Other Study ID Numbers:

S65541

First Posted:

Oct 26, 2021

Last Update Posted:

Oct 26, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 26, 2021