GastroparesisNCT02736799
Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers
A study testing Vibrant Capsule (1 vibration), Vibrant Capsule (3 vibration) and Vibrant Capsule (5 vibration) in people with Gastroparesis, run by Vibrant Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Vibrant Capsule (1 vibration), Vibrant Capsule (3 vibration) and Vibrant Capsule (5 vibration)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)].
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study
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.
Read the 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.
Following an overnight fast, participants underwent introduction of the multilumen manometric catheter into the proximal small intestine with sensors across the antroduodenal junction. A 4-meter Teflon® (green) guidewire and manometry tube were placed transnasally and advanced into the duodenum with the distal end of the manometry tube within the distal duodenum or proximal jejunum.
Following placement of the manometry tube a 30 minute baseline motility assessment was performed followed by the first of two VIBRANT OR SHAM VIBRANT CAPSULES administered as randomly assigned. Motility assessment performed for an additional 25-30 minutes before the digestion of the standardized breakfast test meal. A single spot image will be obtained to document the location of the capsule prior to the meal.
Approximately thirty minutes following ingestion of the capsule, participants ingested a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes. In addition, every 30 minutes one hundred millimeter Visual analog scales (VAS) recorded to assess levels of nausea, fullness, gas, and abdominal pain.
Participants were seated in a semi-recumbent position (~45 degrees) for recording motility and obtaining anterior scintigraphy images simultaneously. Following the 90-minute scan, the participants ingested a second active VIBRANT or sham capsule. Subsequent scans continued at scheduled intervals until 240 minutes after the test meal ingestion to complete the assessment of gastric emptying.
- Conditions
- Gastroparesis
- Being tested
- Sham vibrating capsule, Vibrant Capsule (1 vibration), Vibrant Capsule (3 vibration), Vibrant Capsule (5 vibration)
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham vibrating capsuleDevice
Sham device without vibration
Vibrant Capsule (1 vibration)Device
1 vibration/min
Vibrant Capsule (3 vibration)Device
3 vibration/min
Vibrant Capsule (5 vibration)Device
5 vibration/min
| Study group | Role | What they receive |
|---|---|---|
| Sham vibrating capsule | Sham comparator | Sham vibrating capsule Receives: Device: Sham vibrating capsule |
| Vibrant Capsule (1 vibration) | Active comparator | 1 vibration/min Receives: Device: Vibrant Capsule (1 vibration) |
| Vibrant Capsule (3 vibration) | Active comparator | 3 vibrations/min Receives: Device: Vibrant Capsule (3 vibration) |
| Vibrant Capsule (5 vibration) | Active comparator | 5 vibrations/min Receives: Device: Vibrant Capsule (5 vibration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 hours
Secondary outcomes (3)
Gastric Emptying at One Hour
Gastric emptying scintigraphy (GES) is the 'gold standard' measurement for assessing stomach emptying rate.
Stomach emptying was measured following ingestion of 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.
The outcome of GES at one hour is measuring the rate of solid emptying from the stomach after one hour in each of the study arms.
A higher Fraction of solids emptying represents faster stomach emptying.
Measured: 1 hour
Gastric Emptying at Two Hours
Gastric emptying scintigraphy (GES) is the 'gold standard' measurement for assessing stomach emptying rate.
Stomach emptying was measured following ingestion of 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.
The outcome of GES at two hours is measuring the rate of solid emptying from the stomach after two hours in each of the study arms.
A higher Fraction of solids emptying represents faster stomach emptying.
Measured: 2 hours
Postprandial Distal Antral Motility Index
First 0.5h postprandial distal antral motility index (Gastroduodenal Motility index (MI) MI formula: MI = loge (sum of amplitude x number of contractions + 1). 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 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, an 10% change constitutes a clinically relevant difference.
A higher MI value represents a better outcome.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrant Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736799
- Sponsor's protocol ID
- 215CLD
- Status last verified
- Jul 2024
- First submitted
- 30 Mar 2016
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study
- ClinicalTrials.gov ID
- NCT02736799
- Acronym / sponsor ID
- 215CLD
- Conditions
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vibrant Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Following an overnight fast, participants underwent introduction of the multilumen manometric catheter into the proximal small intestine with sensors across the antroduodenal junction. A 4-meter Teflon® (green) guidewire and manometry tube were placed transnasally and advanced into the duodenum with the distal end of the manometry tube within the distal duodenum or proximal jejunum.
Following placement of the manometry tube a 30 minute baseline motility assessment was performed followed by the first of two VIBRANT OR SHAM VIBRANT CAPSULES administered as randomly assigned. Motility assessment performed for an additional 25-30 minutes before the digestion of the standardized breakfast test meal. A single spot image will be obtained to document the location of the capsule prior to the meal.
Approximately thirty minutes following ingestion of the capsule, participants ingested a standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior gamma camera images obtained immediately following ingestion of the meal and every 15 minutes until 240 minutes. In addition, every 30 minutes one hundred millimeter Visual analog scales (VAS) recorded to assess levels of nausea, fullness, gas, and abdominal pain.
Participants were seated in a semi-recumbent position (~45 degrees) for recording motility and obtaining anterior scintigraphy images simultaneously. Following the 90-minute scan, the participants ingested a second active VIBRANT or sham capsule. Subsequent scans continued at scheduled intervals until 240 minutes after the test meal ingestion to complete the assessment of gastric emptying.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham vibrating capsule | Sham comparator | Device: Sham vibrating capsuleSham vibrating capsule |
| Vibrant Capsule (1 vibration) | Active comparator | Device: Vibrant Capsule (1 vibration)1 vibration/min |
| Vibrant Capsule (3 vibration) | Active comparator | Device: Vibrant Capsule (3 vibration)3 vibrations/min |
| Vibrant Capsule (5 vibration) | Active comparator | Device: Vibrant Capsule (5 vibration)5 vibrations/min |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)].
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham vibrating capsuleSham device without vibration | Device | Sham vibrating capsule |
| Vibrant Capsule (1 vibration)1 vibration/min | Device | Vibrant Capsule (1 vibration) |
| Vibrant Capsule (3 vibration)3 vibration/min | Device | Vibrant Capsule (3 vibration) |
| Vibrant Capsule (5 vibration)5 vibration/min | Device | Vibrant Capsule (5 vibration) |
Primary outcome
Gastroduodenal Manometry Measurement
Time frame: 1 hour
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.
Gastric Emptying of Solids - T1/2
Time frame: 4 hours
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.
3 secondary outcomes
Gastric Emptying at One Hour
Time frame: 1 hour
Gastric Emptying at Two Hours
Time frame: 2 hours
Postprandial Distal Antral Motility Index
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant Capsule (1 vibration), Vibrant Capsule (3 vibration) and Vibrant Capsule (5 vibration) in people with Gastroparesis, run by Vibrant Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroduodenal Manometry Measurement (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.