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The Vibrant capsule is a novel vibrating device for the treatment of gastrointestinal disorders. The effect of different vibrations on the motor functions of the gastrointestinal tract are unclear. The study will focus on the stomach in healthy volunteers.
The study will compare the effects of Vibrant capsule treatment and Sham capsule treatment on gastric emptying and gastric motility in healthy volunteers.
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Exclusion criteria
Unable or unwilling to provide informed consent or to comply with study procedures
Diagnosis of gastrointestinal diseases
Structural or metabolic diseases that affect the gastrointestinal system
Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:
History of recent surgery (within 60 days of screening)
Acute or chronic illness or history of illness which, in the opinion of the investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data, such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator
Acute gastrointestinal illness within 48 hours of initiation of the baseline period
Females who are pregnant or breastfeeding
History of excessive alcohol use or substance abuse
Participation in an investigational study within the 30 days prior to dosing in the present study
Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study
24 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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