Status:
COMPLETED
Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers
Lead Sponsor:
Vibrant Ltd.
Conditions:
Gastroparesis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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. Th...
Detailed Description
Healthy volunteers participants were randomized to one of 4 treatment groups: sham VIBRANT or vibrating VIBRANT capsule at rates of 1, 3 or 5 per minute. The studies were conducted in one day. Follow...
Eligibility Criteria
Inclusion
- Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
- No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
- Body mass index of 18-35 kg/m2
- Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record \[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\].
Exclusion
- 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:
- Medications that alter gastrointestinal transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin
- Analgesic drugs including Nonsteroidal Anti-Inflammatory Drugs and COX-2 inhibitors NOTE: stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.
- 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
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02736799
Start Date
March 1 2016
End Date
December 1 2016
Last Update
August 15 2024
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905