The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

Motility Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05093010
• Other study ID #: S65541
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Motility Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

References & 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. Revi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess correlation between electrogastrography abnormality and upper gastrointestinal symptoms.	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.	30 minutes before the meal and 4 hours after having meal.