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NCT05880199 · ClinicalTrials.gov registry record
BSGM to Evaluate Patients With GI Symptoms
A clinical trial of Gastroparesis and Functional Gastrointestinal Disorders, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- 685
- Enrollment target
- 5
- Study locations
NCT05880199: Recruiting study of Gastroparesis and Functional Gastrointestinal Disorders, sponsored by Children's Hospital of Philadelphia.
NCT05880199 is a study of Gastroparesis and Functional Gastrointestinal Disorders that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 685 participants, above the 287-participant average among 44 other Gastroparesis trials with a reported enrollment target (139% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05880199, a study of Gastroparesis and Functional Gastrointestinal Disorders, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- 685 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Healthy children will be recruited to provide BSGM reference range data. Control data will be used to compute normative data ranges for each key BSGM metric before and after the test meal: slow wave direction, pattern, velocity, frequency, and amplitude. For reference ranges: * BMI-adjusted amplitude: normal reference range at 5-95% CI * Rhythm-Index: normal reference range with cutoff \<5% CI * Frequency: 5-95% CI * Fed: fasted amplitude ratio: \<5% CI * Slow wave pattern: descriptive These
Conditions Studied
Interventions
- DEVICE Body surface gastric mapping device
Study Locations (5)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
California
- Alliant International University - San Diego
Missouri
- Children's Mercy Hospital - Kansas City
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 685 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2028-06-30 |
What NCT05880199 shows while recruiting
NCT05880199 is an observational study that tracks outcomes without assigning an intervention. The registered 685 participants enrollment target is mid-sized for trials with a published cap, above the 287-participant average among 44 other Gastroparesis trials with a reported enrollment target (139% higher).
The record links to 4 conditions, with Gastroparesis appearing as the primary indexed condition, and to 1 intervention - of which Body surface gastric mapping device is the first listed.
NCT05880199 lists 5 locations in 4 states (Ohio, California, Missouri).
Frequently Asked Questions
What is clinical trial NCT05880199 about?
NCT05880199 is a clinical study titled "BSGM to Evaluate Patients With GI Symptoms". 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...
What is the current status of trial NCT05880199?
This trial is currently recruiting. The enrollment target is 685 participants. The study started on 2021-10-01. Estimated completion is 2028-06-30.
What conditions does trial NCT05880199 study?
This clinical trial studies the following conditions: Gastroparesis, Functional Gastrointestinal Disorders, Gastrointestinal Motility Disorders in Children, Dyspepsia and Other Specified Disorders of Function of Stomach.
What interventions are being tested in trial NCT05880199?
The interventions under investigation include: Body surface gastric mapping device (DEVICE).
Who is sponsoring clinical trial NCT05880199?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05880199 being conducted?
This trial has 5 study locations across California, Missouri, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05880199's enrollment target sits among peer trials
685 3rd of 44 higher than 42 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
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