Effect of Vibrant Capsule on Gastric Emptying and Antropyloroduodenal Motility in Healthy Volunteers: A Sham Device Controlled, Single Center Pilot Study
Phase: NA
Conditions: Gastroparesis
Sponsor: Vibrant Ltd.

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 1 of 19 
 
 
NCT Number - NCT02736799 
 
 
 
 
Title of the Study:
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers: A Sham Device Controlled, 
Single Center Pilot Study 
 
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 2 of 19 
 
 
 
Abstract
 
 
Background
  
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. 
 
 
Hypothesis
 
VIBRANT capsule treatment results in acceleration of gastric emptying and stimulation of 
gastric motility in healthy volunteers.
 
Aim
 
To compare the effects of VIBRANT capsule treatment and SHAM capsule treatment on gastric 
emptying and gastric motility in healthy volunteers.
 
Methods
 
We shall perform simultaneous antropyloroduodenal manometry and scintigraphic gastric 
emptying of solids in 24 healthy volunteers, 6 volunteers per treatment arm with VIBRANT 
capsule programmed to deliver 0, 1, 3 or 5 vibrations per minute for a period of 4 hours starting 
15 minutes after ingestion. This is a pilot study to evaluate potential effects of the VIBRANT 
capsule on stimulation of gastric motor functions.
 
 
Significance
 
This study will provide new information about the ability of the VIBRANT capsule to impact 
contractility in the stomach and will determine if specific vibrations patterns result in different 
contractile activity. 
 
In addition, this study will form the foundation for subsequent application of this method for 
treatment of motility and functional disorders of the lower stomach, particularly in patients with 
gastroparesis.  
 
 
 
  

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 3 of 19 
 
 
 
Research Plan
 
 
HYPOTHESES AND SPECIFIC AIM
 
 
Hypothesis
 
VIBRANT capsule treatment results in acceleration of gastric emptying and stimulation of 
gastric motility in healthy volunteers.
 
Aim
 
To compare the effects of three different VIBRANT capsule treatment modes (1, 3 and 5 
vibrations per minute) and SHAM capsule treatment on gastric emptying and gastric motility in 
healthy volunteers.
 
 
BACKGROUND 
 
The VIBRANT capsule’s mechanism of action is still unknown, as well as the effect of different 
vibration patterns. This study will test for the first time the hypothesis that the VIBRANT 
capsule effects contractility and analyze the effects of different vibration pattern on stomach 
contractility.
 
Furthermore, there is continued unmet need for effective treatments for patients with 
gastroparesis (1). 
 
 
RESEARCH DESIGN AND METHODS  
 
 
Study Design
 
This is a randomized, double-blind, sham-controlled, parallel-group pilot study. Twenty-four 
healthy volunteers will be recruited, enrolled, and randomized to one of 4 treatment groups.  
Subjects meeting all inclusion/exclusion criteria will be randomized to either sham VIBRANT or 
vibrating VIBRANT capsule at rates of 1, 3 or 5 per minute. The actual studies will be conducted 
on one day.
 
 
 
Participants
 
Male and female subjects, aged 18 to 65 years at screening, who meet the following inclusion 
and exclusion criteria will be eligible for enrollment: 
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 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 4 of 19 
 
 
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 GI system 
4. Unable to avoid the following over-the-counter medications 48 hours prior to the baseline 
period and throughout the study: 
a.  Medications that alter GI transit including laxatives, magnesium and aluminum containing 
antacids, prokinetics, erythromycin  
b.  Analgesic drugs including NSAIDs 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 GI 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 
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 5 of 19 
 
 
Gastric Motility Studies
 
 
Participants will come to the Clinical Research Unit on the 7th floor of the Charlton Building at 
Mayo Clinic. They will arrive fasting, at a predetermined scheduled appointment time. A urine 
pregnancy test will be performed, when applicable, within 48 hours of the start of the test.  
 
 
Following an overnight fast, subjects will undergo introduction of the multilumen manometric 
catheter into the proximal small intestine with sensors across the antroduodenal junction. Trained 
technologist (DB) and staff physician (MC) will perform the manometry tube placement in 
accordance with standard practice over the past 25 years. A 4-meter Teflon® (green) guidewire 
and manometry tube will be placed transnasally and advanced into the duodenum with the distal 
end of the manometry tube within the distal duodenum or proximal jejunum. The position of the 
manometry tube will be verified using fluoroscopy to ensure that the 12 manometric sensors that 
are 1 cm apart are located across the antropyloroduodenal junction.  Following placement of the 
manometry tube a 30 minute baseline motility assessment will be performed followed by the first 
of two VIBRANT OR SHAM VIBRANT CAPSULES will be administered as randomly 
assigned.  Motility assessment will be 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, subjects will ingest a 
standardized breakfast meal (320kcal egg, toast, milk) containing 99mTc. Anterior and posterior 
gamma camera images will be 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) will be recorded to assess levels of nausea, fullness, gas, and abdominal 
pain.  Subjects will be seated in a semi-recumbant position (~45 degrees) for recording of 
motility and obtaining anterior scintigraphy images, simultaneously.  Following the 90 minute 
scan the subject will ingest a second active VIBRANT or sham capsule.  Subsequent scans will 
continue at scheduled intervals until 240 minutes after the test meal ingestion in order to 
complete the assessment of gastric emptying.  At the conclusion, the subject will be escorted to 
the fluoroscopy room for a spot image to document the location of both capsules.  Following the 
spot image, the multilumen manometric catheter will be removed and the subjects will be 
dismissed.  The total duration of the study is ~6 hours.  Subjects will leave the study center at the 
end of the study. 
  
Transit Data Analysis
 
 
A variable region of interest program is used to quantitate the counts in stomach.  These counts 
will be corrected for isotope decay, and tissue attenuation.
 
 
Data will be analyzed as in previous studies using geometric mean of counts in stomach.
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 6 of 19 
 
 
 
Gastric Motility 
See Appendix Radiation Exposure for assessment of radiation exposure levels from fluoroscopy. 
Each of the channels of the multi-lumen manometric 
tube will be perfused with distilled water via a 
pneumohydraulic pump (perfusion rate 0.15mL/min, 
perfusion pressure 14psi) and attached to a strain gauge 
transducer (model PX-MK099, Edwards Lifesciences, 
Irvine, CA.). One side opening has been made in each 
channel of the multi-lumen tube, and the positions of 
these openings will be fluoroscopically placed across the 
antroduodenal region; thus, the tip of the tube will lie 
within approximately 10cm of the ligament of Treitz.  
Gastrointestinal pressure activity will be recorded in 
each subject for 1 hour while fasted. Then, each 
individual will ingest a 320-calorie mixed solid-liquid 
meal consisting of 2 eggs, bran bread toast, and 240mL 
of skim milk.   
Pressure activity will be recorded for 5 hours (2) while 
participants are seated at a 45 degree angle. 
 
 
 
Figure 2 shows an example of the inhibition of postprandial antral motility and forces with lipid 
and stimulation by erythromycin (3).  
 
Figure 1. Multi-lumen manometric 
assembly in the upper 
gastrointestinal tract to measure 
distal antral motility in 
postprandial period 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 7 of 19 
 
 
Antral pressure activity determines the rate of gastric emptying of solids.  
Figure 3 shows a correlation between distal antral contraction amplitude and rate of gastric 
emptying (3).  
 
 
Analysis of Manometric Recordings  
Phasic pressure activity in the distal antrum recorded on the manometric tracing will be 
quantified manually. The  most distal antral site will be identified as a site recording up to three 
waves per minute which are (a) just proximal (1 cm) to a site recording duodenal-type waves or 
(b) just proximal to a site exhibiting a mixture of antral-type and duodenal-type waves associated 
with baseline elevation (pyloric-type activity). For each sequential 15-minute period and for the 
entire 2-hour postcibal period, a motility index (MI) will be calculated using the formula: MI = 
loge (sum of amplitude x number of contractions + 1). The average 15-minute antral motility 
index will be then calculated; previous studies have shown that the cumulated slope of antral 
motility indices is linear (4).  
 
Statistical Analysis 
for analysis will be:
 
primary endpoints
The 
 
a. Gastroduodenal manometry (GDM) measurement of first hour postprandial distal antral 
motility index. 
b. Gastric emptying of solids:T1/2 and lag time in minutes 
 
will be:
 
secondary endpoints
The 
 
a. Gastric emptying at 1h  
b. Gastric emptying  at 2h  
c. First 0.5h postprandial distal antral motility index 
d. Abdominal Symptom assessments-VAS 
 
The effects of the VIBRANT CAPSULE treatment on the primary and secondary response 
measures will be assessed using an analysis of covariance (ANCOVA) with suitable 
transformation for skewness in the distributions of measured parameters (e.g., ANCOVA on 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 8 of 19 
 
 
ranks, if necessary).  The covariates considered for inclusion in the analyses will be age, gender, 
and body mass index.  
 
 
Administrative look
 
 
Administrative look will be done when 12 subjects completed the study.  
 
The objective of the administrative look is to assist in future development of the medical device 
 
 
The process:
 
 
1. The study site of Mayo who continue to enroll and assess the HV subjects in the study 
continue to be blinded, thus no treatment assignment is revealed nor any potential bias may be 
associated with the process.
 
2. Sponsor Staff especially the clinical team who communicate with the study site staff will 
continue to be blinded.
 
3. The sponsor decision making responsible person, will receive the data of the 1st 12 subjects ( 
3 /arm : shame, 1,3 and 5 vibrating modes ) will be blinded to subject numbers and get the data 
per treatment arm with No Subjects Identification
 
4. Since this analysis is for administrative purposes and No changes to the Clinical Trial Protocol 
will be made as a result of looking at the data, the P Value remain Unadjusted ( does not change)
 
5. Descriptive Rather than Inferential analysis.
 
 
Sample Size Assessment 
 
 
Table 1 below summarizes data for the primary response measures and uses the (relative) 
variation (CV%) to estimate the effect size detectable with 80% power based on a two-sample t-
test (i.e., assuming the variation values are known) at a two-sided alpha level of 0.05. The effect 
size is the difference in group means as a percentage of the overall mean for each response and 
assumes 6 subjects per group. The ANCOVA should provide 80% power to detect similar 
(pairwise) differences using a pooled estimate of variation across all three groups and potentially 
even smaller effect sizes by adjusting for important covariates. The data from the scintigraphic 
transit studies are unpublished, but are based on the same methods proposed for this study.
 
Sample size assessment is based on the results of primary endpoints in our laboratory [data show 
mean ± SD). The standard deviation used for the sample size calculations was calculated from 
the observed number of distal antral activity in healthy volunteers in the absence of any 
treatment: 11.5±0.6 (SD) (2,4,5).  
 
Table 1.  Primary Response Measures 
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 9 of 19 
 
 
Response 
Mean 
SD 
Effect size detectable, n=4 per group, absolute (%) 
Postprandial distal 
antral MI* 
11.5 
0.6 
1.184 (10.3% change) 
Gastric emptying 
T1/2 (min) 
121.7 
29.6 
58.4 min (48% change) 
 
*Based on data from previous studies (2,4-6). 
Effect size is the difference between means as a percentage of listed mean index between the two 
treatment groups (shown in table with 80% power, α =0.05). 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 (2,4,5). It is to be 
noted that this is on a logarithmic scale and, therefore, an 10% change constitutes a clinically 
relevant difference.   
 
Clinical or Biological Relevance of Change in Antral Motility Index 
 
The magnitudes of the changes detectable are clinically relevant or have been observed in prior 
studies using pharmacological agents such as cisapride and erythromycin. 
 
Effect of Cisapride on Antral Motility Index 
 
Cisapride resulted in a significant increase in the gastric emptying of solids (p <0.05) compared 
with placebo, and cisapride also tended to increase the postprandial antral motility (7). The 
difference in the 2-hour antral motility index (median values) was 0.75 units. 
 
Table 2. Postprandial Antral Motility Index at 2 Hours (median) 
Gastroparesis group (N) 
2-h postprandial median antral motility index 
Cisapride (6) 
13.38 
Placebo (6) 
12.63 
There was no effect of placebo on gastric emptying in contrast to the effect of cisapride, and 
these effects on the antral motility index were associated with significant changes in gastric 
emptying (particularly of solids).   

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 10 of 19 
 
 
Figure 4 (upper panel) shows median gastric emptying 
plots for placebo treatment (baseline and 6 weeks) in 
subjects with gastroparesis and chronic intestinal pseudo-
obstruction, and healthy controls. The lower panel shows 
similar data for the subjects receiving placebo, with 
baseline and 6-week data presented. Note that cisapride 
accelerates gastric emptying.   
 
 
 
 
 
 
Effect on Gastric Emptying
 
is in the clinical range that can 
1/2 
A 48% change in gastric emptying T
be expected to be relevant, as shown in studies using gastric emptying 
scintigraphy in patients with diabetes and upper GI symptoms (8).  For 
example, the ghrelin agonist RM-131 has such an effect (54%) on 
1/2
gastric emptying T
 
Figure 5 shows an example of gastric emptying profile from a 
patient with type I diabetes treated on se
 
parate occasions with 
131 (relamorelin) 
-
placebo and RM
 
 
Therefore, the effect size demonstrable in the prioposed study would be clinically relevant, 
justifying the proposed design and sample size in each of the three treatment groups.
 
 
Strengths and Limitations
 
The major strengths of this study include the ability to noninvasively measure gastric emptying, 
as well as the resources available in the Clinical Research Unit on Charlton 7.  Therefore, 
completion of this study is highly feasible. We have a well-established track record using these 
techniques in patients with diverse lower gastrointestinal functional disorders in previous studies. 
We have sufficient power to detect clinically relevant differences between the treatment groups. 
Variability in body size and weight are accounted for by inclusion as covariates in the ANCOVA 
analysis of transit parameters. 
 
Feasibility and Time Frame 
This study involves one noninvasive gastric transit study with simultaneous antropyloroduodenal 
manometry measurement in healthy volunteers. The study is feasible.  Based on past experience, 
recruitment of study subjects should be uncomplicated. 
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 11 of 19 
 
 
 
 
Anticipated Results and Significance
 
We anticipate that VIBRANT capsule (compared to SHAM) will impact stomach contractility. 
and 
 
will accelerate gastric emptying. This study will form the foundation for subsequent application 
of this method for treatment of motility and functional disorders of the gastrointestinal tract, 
particularly in subjects with gastroparesis.  
 
 
HUMAN SUBJECTS SAFETY 
 
 
Recruitment and Consenting of Participants and Gender/Minority Mix
 
 
Twenty-four healthy participants will be recruited from the local community by public 
advertisement as part of the main study protocol.
 
  
Subjects will be recruited by public advertisement:
 
Healthy volunteers, aged 18-65 years, are needed for a study to evaluate the effect of an 
experimental therapy, VIBRANT capsule, on movement of the stomach. This study 
requires taking study capsule administered orally once, and noninvasive gastric emptying 
and tube measured gastric motility on one occasion. Remuneration offered. For more 
boldingh.amy@mayo.edu
6599 or send email to 
-
information, call Amy Boldingh at 538
 
 
Informed consent will be obtained by the principal investigator or study coordinator following 
both a review of the written consent form and a conversation outlining the risks, benefits, and 
goals of the investigation.  Documentation will be recorded with signatures of the study 
participant and the individual obtaining consent (on the standard informed consent document).
 
This study cohort will reflect the population of Olmsted County, Minnesota with 90% Caucasian, 
5% Asian and 5% other. Previous experience would suggest an age range of volunteers from 18-
65 years, with a mean age of approximately 45 years. No subpopulations or special classes of 
subjects are involved in this trial. 
 
There are no known ethnic or gender differences in the effects of VIBRANT CAPSULE.  Hence, 
we anticipate the results of our study will be generalizable.
 
 
Research Materials  
 
Facilities and equipment are available for these studies in the GI Physiology Core Laboratory of 
the Clinical Research Unit on Charlton 7. All data retrieved during the study will be used 
specifically for research purposes.
 
 
Potential Risks and Protection in Substudy
 
The study involves the use of radiation that is within limits permissible for healthy volunteers.  
The PI has >28 years’ experience with these methods. The study device safety to date in healthy 
volunteers has been excellent.
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 12 of 19 
 
 
Definitions of adverse event and serious adverse events are included in the main study.
 
 
is within permissible limits for human volunteer studies.  All female 
 
Radiation exposure
participants who are still menstruating and have not been surgically sterilized will have a 
negative pregnancy test within 48 hours of the study.  
 
The table shows the radiation organ dose exposure per radiopharmaceutical dosing for the gastric 
emptying tests. 
 
  
Radiophar- Act  Body Gonads Breast Red Lung Thyroid Bone ULI Colon Stom Blad  Liv Esoph Other  
 
maceutical mCi
 
 
marrow
              
 
  
 
 
_
agus
-
er  
-
der   
-
ach   
-
                   
 
 
10      220
    
130   20     
    
420     300    
 
            
20                                  
 
    
1.0          20         90                 
 
s.c.
 ,
Tc
99m
 
(mrad= radiation absorbed dose to organs)
 
to the body summarizes the risk to the whole body as the 
 
or the radiation effective dose
e 
H
individual doses to each of the organs; effective dose is used to compare risks among various 
(mrem = radiation 
 
1.0 mCi, He90 mrem
 
SC,
-
Tc
99m
ray and radionuclide studies:  
-
types of x
equivalent dose)
 
 
Radiation Exposure from Fluoroscopy  
Average time, <1minute; no more than 2 minutes will ever be used. 
 
 
All imaging will be undertaken by trained technicians in the laboratory with 30 years’ aggregate 
experience using scintigraphic techniques. 
 
 
BENEFITS
 
 
There are no benefits for participants in this study.  Participants may choose not to participate.  
 
 
STUDY REPORT AND PUBLICATION POLICY
 

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 13 of 19 
 
 
 
After conclusion of the study, the investigator will analyze the data and write a report for 
publication. The study sponsor will have the opportunity to review the study data according to 
the conditions stipulated in the contract developed by Mayo Clinic Legal Department. 
Publication rights are specifically identified in the contract.
 
 
BUDGET (attached)
 
 
Budget Justification
 
 
PERSONNEL
 
 
will be responsible for the clinical conduct of the study and overseeing the 
Dr. M. Camilleri, 
 
coordinators and technologists. 
 
will work under the direction of the site Principal Investigator, Dr. M. 
 
Research fellows
.
Camilleri
 
) will 
Rhoten, and Michael Ryks
 
orah
Duane Burton, Deb
Trained technologists (
 :
Technologists
be involved in the synthesis of radioisotopic materials in the "hot lab" in the CRU in Charlton 7. 
They will also conduct the acquisition of images. The physiologic testing of this study requires 1 
day of participation per subject; there will be 12 participants. The technologists will be 
responsible for the analysis of scintigraphy imaging. They will place all data in an EXCEL 
spreadsheet for further analysis.
 
Clinical research coordinators will be responsible for recruiting and scheduling 
: 
Coordinators
examination of participants and maintenance of study records (case report forms and symptom 
recordings). These coordinators will notify the PI of any adverse events, maintain records and 
documentation for IRB, and work with study monitors.
 
: A biostatistician from the Mayo Clinic Department of Biomedical Statistics 
Data analyst
requires data analyst support for randomization schedule, "clean up" and final analysis of study 
data in this study. This will be accomplished by one of the analysts assigned to his area in the 
Department of Biostatistics.
 
 
  

 
Vibrating Capsule 
 
Effect of VIBRANT Capsule on Gastric 
Emptying and Antropyloroduodenal Motility in 
Healthy Volunteers – Study no. V102 
Doc. no.215CLD rev.04  
Date: February 1st, 2016  
Page 14 of 19 
 
 
REFERENCES 
 
 
1.  Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L. Clinical guideline: management 
of gastroparesis. Am J Gastroenterol 108:18-37, 2013
 
2.  Camilleri M, Brown ML, et al. Relationship between impaired gastric emptying and abnormal 
gastrointestinal motility. Gastroenterology 91:94-99, 1986
 
3.  Prather CM, Camilleri M, Thomforde GM, Forstrom LA, Zinsmeister AR. Gastric axial 
forces in experimentally-delayed and accelerated gastric emptying.  Am J Physiol 264:G928-
G934, 1993
 
4.  Camilleri M, Malagelada JR, et al. Relation between antral motility and gastric emptying of 
solids and liquids in humans. Am J Physiol 249:G580-G585, 1985
 
5.  Camilleri M, Malagelada JR, et al. Gastrointestinal motility disturbances in patients with 
orthostatic hypotension. Gastroenterology 88:1852-1859, 1985
 
6.  Camilleri M, Iturrino J, et al. Performance characteristics of scintigraphic measurement of 
gastric emptying of solids in healthy participants. Neurogastroenterol Motil 24:1076-e562, 
2012      
 
7.  Camilleri M, Malagelada JR, Abell TL, Brown ML, Hench V, Zinsmeister AR. Effect of six 
weeks of treatment with cisapride in gastroparesis and intestinal pseudoobstruction.  
Gastroenterology 96:704-712, 1989
 
8. Shin A, Camilleri M, Busciglio I, Burton D, Smith SA, Vella A, Ryks M, Rhoten D, 
Zinsmeister AR.  Ghrelin agonist RM-131 accelerates gastric emptying of solids and reduces 
symptoms in patients with type 1 diabetes mellitus.  Clin Gastroenterol Hepatol 11:1453-1459, 
2013