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

NCT02736799 | Completed Results FDA Device

• 1 other identifier: 215CLD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (2)

• Gastroduodenal Manometry Measurement

  The main outcome measure is the Gastro-duodenal manometry measurement of the first hour postprandial distal antral motility index (MI), which is calculated as: MI = loge (sum of amplitude x number of contractions + 1) every 15 minutes following postcibal period (60 min). Effect size is the difference between means as a percentage of the mean index between the treatment groups. Estimated effect sizes are based on a paired t-test with the expected difference in mean of 1.6 motility index units in distal antral activity or 13.6% change in the antral motility index in ACTIVE compared to SHAM. It is to be noted that this is on a logarithmic scale and, therefore, a 10% change constitutes a clinically relevant difference. A higher MI value represents a better outcome.

  1 hour

• Gastric Emptying of Solids - T1/2

  The median solid gastric emptying half-time in minutes from the stomach after a mixed meal as measured by scintigraphy. Approximately thirty minutes following ingestion of the Vibarnt / sham capsule, subjects ingested a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images were obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes.

  4 hours

Secondary Outcomes (3)

• Gastric Emptying at One Hour

  1 hour

• Gastric Emptying at Two Hours

  2 hours

• Postprandial Distal Antral Motility Index

  30 minutes

Study Arms (4)

Sham vibrating capsule

SHAM COMPARATOR

Sham vibrating capsule

Device: Sham vibrating capsule

Vibrant Capsule (1 vibration)

ACTIVE COMPARATOR

1 vibration/min

Device: Vibrant Capsule (1 vibration)

Vibrant Capsule (3 vibration)

ACTIVE COMPARATOR

3 vibrations/min

Device: Vibrant Capsule (3 vibration)

Vibrant Capsule (5 vibration)

ACTIVE COMPARATOR

5 vibrations/min

Device: Vibrant Capsule (5 vibration)

Interventions

Sham vibrating capsule DEVICE

Sham device without vibration

Sham vibrating capsule

Vibrant Capsule (1 vibration) DEVICE

1 vibration/min

Vibrant Capsule (1 vibration)

Vibrant Capsule (3 vibration) DEVICE

3 vibration/min

Vibrant Capsule (3 vibration)

Vibrant Capsule (5 vibration) DEVICE

5 vibration/min

Vibrant Capsule (5 vibration)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period)\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tal Malina / Clinical trials manager
• Organization: Vibrant LTD

tal.m@vibrantgastro.com

+972 046663322

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-07

Locations

US (1)