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Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02736799
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Vibrant Ltd.

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. 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.


Condition or disease Intervention/treatment Phase
Gastroparesis Device: Sham vibrating capsule Device: Vibrant Capsule (1 vibration) Device: Vibrant Capsule (3 vibration) Device: Vibrant Capsule (5 vibration) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study
Study Start Date : March 2016
Actual Primary Completion Date : December 2016

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Arm Intervention/treatment
Sham Comparator: Sham vibrating capsule
Sham vibrating capsule
Device: Sham vibrating capsule
Sham device without vibration

Active Comparator: Vibrant Capsule (1 vibration)
1 vibration/min
Device: Vibrant Capsule (1 vibration)
1 vibration/min

Active Comparator: Vibrant Capsule (3 vibration)
3 vibrations/min
Device: Vibrant Capsule (3 vibration)
3 vibration/min

Active Comparator: Vibrant Capsule (5 vibration)
5 vibrations/min
Device: Vibrant Capsule (5 vibration)
5 vibration/min




Primary Outcome Measures :
  1. Gastroduodenal manometry measurement of first hour postprandial distal antral motility index. [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. Gastric emptying of solids:T1/2 in minutes (scintigraphy) [ Time Frame: 5 hours ]
  2. Gastric emptying of solids: lag time in minutes (scintigraphy) [ Time Frame: 5 hours ]
  3. Gastric emptying at 1h (scintigraphy) [ Time Frame: 1 hour ]
  4. Gastric emptying at 2h (scintigraphy) [ Time Frame: 2 hours ]
  5. First 0.5h postprandial distal antral motility index (Gastroduodenal manometry) [ Time Frame: 30 minutes ]
  6. Abdominal Symptom assessments - VAS [ Time Frame: 5 hours ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
  2. No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
  3. Body mass index of 18-35 kg/m2
  4. 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 Criteria:

  1. Unable or unwilling to provide informed consent or to comply with study procedures
  2. Diagnosis of gastrointestinal diseases
  3. Structural or metabolic diseases that affect the gastrointestinal system
  4. Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:

    1. Medications that alter gastrointestinal transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin
    2. 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.
  5. History of recent surgery (within 60 days of screening)
  6. 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.
  7. Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator
  8. Acute gastrointestinal illness within 48 hours of initiation of the baseline period
  9. Females who are pregnant or breastfeeding
  10. History of excessive alcohol use or substance abuse
  11. Participation in an investigational study within the 30 days prior to dosing in the present study
  12. Any other reason, which in the opinion of the investigator, would confound proper interpretation of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736799


Locations
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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Vibrant Ltd.
Investigators
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Principal Investigator: Michael Camilleri, MD Mayo Clinic

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Responsible Party: Vibrant Ltd.
ClinicalTrials.gov Identifier: NCT02736799     History of Changes
Other Study ID Numbers: 215CLD
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms