The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Motility Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

References

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Carson DA, O'Grady G, Du P, Gharibans AA, Andrews CN. Body surface mapping of the stomach: New directions for clinically evaluating gastric electrical activity. Neurogastroenterol Motil. 2021 Mar;33(3):e14048. doi: 10.1111/nmo.14048. Epub 2020 Dec 4.

Reference Type RESULT

PMID: 33274564 (View on PubMed)

Other Identifiers

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S65541

Identifier Type: -

Identifier Source: org_study_id