Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05880199

BSGM to Evaluate Patients With GI Symptoms

Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
685 (estimated)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
8 Years – 25 Years
Healthy volunteers
Accepted

Summary

The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.

Detailed description

This is an prospective, multi-cohort study that will focus on adaptation and optimization of a novel non-invasive device called 'Body Surface Gastric Mapping (BSGM)' for use in children including defining and optimizing normal ranges in healthy children, defining abnormal patterns in children with GI symptoms, comparing BSGM patterns with currently used diagnostic tests, and evaluating the mechanisms behind current therapeutic interventions using BSGM patterns as biomarkers.

Conditions

Interventions

TypeNameDescription
DEVICEBody surface gastric mapping deviceA medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

Timeline

Start date
2021-10-01
Primary completion
2027-12-31
Completion
2028-06-30
First posted
2023-05-30
Last updated
2026-02-10

Locations

5 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05880199. Inclusion in this directory is not an endorsement.