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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT04607304
Eligibility Criteria:
Inclusion Criteria:
* Males and females, 18-85 old at time of signing the informed consent form fro healthy and intended use population participants (i.e. symptomology of gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration.
* Ability to eat test meal and provide breath samples
Exclusion Criteria:
* History or physical exam suggestive of pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease or malabsorption syndrome
* History of abdominal surgery except appendectomy
* Use of any medications that may alter gastric motility within two days of the study
* Use of narcotics or anticholinergics within two days of the study
* Females on hormone replacement therapy other than birth control medications
* Receipt of an investigational drug within 4 weeks of the study
* Pregnancy
* Intolerance or allergy to any component of Gastric Emptying Breath Test meal
* History of neurologic or psychiatric disorders
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04607304
Study Brief:
Protocol Section:
NCT04607304