Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT04684992
Eligibility Criteria:
Inclusion Criteria:
* Males and females, greater than or equal to 18 years of age at the time of signing the consent form, from healthy and intended use population (i.e. symptomatic for gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration.
* Ability to eat test meal and provide breath samples
* Access to a microwave oven at home
* Internet connection and telehealth accessible device (smart phone/tablet/computer with visual and voice capability) at home
* Environment to sit comfortably and quietly at home
Exclusion Criteria:
* History or physical exam suggestive of systemic disease such as pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption syndrome
* History of abdominal surgery except appendectomy
* Females on hormone replacement therapy other than birth control medications
* Receipt of any investigational drug within 4 weeks of the study
* Pregnancy
* Intolerance or allergy to any component of GEBT meal
* History of neurological or psychiatric disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04684992
Study Brief:
Protocol Section:
NCT04684992