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

Gastroparesis Clinical Trial

Official title:

Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736799
• Other study ID #: 215CLD
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: January 11, 2017
• Start date: March 2016

Study information

• Verified date: January 2017
• Source: Vibrant Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• Sham vibrating capsule
Sham device without vibration
• Vibrant Capsule (1 vibration)
1 vibration/min
• Vibrant Capsule (3 vibration)
3 vibration/min
• Vibrant Capsule (5 vibration)
5 vibration/min

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Vibrant Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastroduodenal manometry measurement of first hour postprandial distal antral motility index.		5 hours	No
Secondary	Gastric emptying of solids:T1/2 in minutes (scintigraphy)		5 hours	No
Secondary	Gastric emptying of solids: lag time in minutes (scintigraphy)		5 hours	No
Secondary	Gastric emptying at 1h (scintigraphy)		1 hour	No
Secondary	Gastric emptying at 2h (scintigraphy)		2 hours	No
Secondary	First 0.5h postprandial distal antral motility index (Gastroduodenal manometry)		30 minutes	No
Secondary	Abdominal Symptom assessments - VAS		5 hours	No