The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

NCT05093010 | Unknown

• 1 other identifier: S65541
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Motility Disorder

Outcome Measures

Primary Outcomes (1)

• Validation of body surface gastric mapping for delayed gastric emptying

  The correlation of electrogastrography abnormality (in percentage) and delayed gastric emptying (t 1/2, minutes) will be determined employing a regression method.

  30 minutes before the meal and 4 hours after having meal.

Secondary Outcomes (1)

• To assess correlation between electrogastrography abnormality and upper gastrointestinal symptoms.

  30 minutes before the meal and 4 hours after having meal.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who will receive gastric emptying breath test

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (1)

• 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.

  PMID: 33274564 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 26, 2021
• Study Start: October 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share