Gastric Myoelectric Activity With Water Load Satiety Test as a Predictor of Individual Successful Response to Treatment by Various Bariatric Procedures.
Phase: NA
Conditions: Bariatric Surgery, Gastric Motor Dysfunction, Gastroparesis
Sponsor: Asian Institute of Gastroenterology, India

 
Protocol No: EGG01 ; Version: 1.0 ; dt: 09 Jul 2022 
 
STUDY PROTOCOL 
Study Title: GASTRIC MYOELECTRICAL ACTIVITY WITH WATER LOAD 
SATIETY TEST AS A PREDICTOR OF INDIVIDUAL SUCCESSFUL 
RESPONSE TO TREATMENT BY VARIOUS BARIATRIC PROCEDURES 
Promoted by GETTEMO-SEED 
Director of the Study: Dr. Eduardo Espinet-Coll 
Coordinator of the Study: Dr Carmen Bautista-Altamirano 
 
Protocol No: 
Product Name: NA 
Type of Study: Investigator Initiated study 
Date: June 25, 2022 
Principal Investigator: Dr. Rakesh Kalapala 
Consultant Gastroenterologist &amp; Therapeutic Endoscopist, 
Director - Endoscopy (Center for Obesity &amp; Metabolic Therapy) 
Email: drrakesh.kalapala@aighospitals.com 
 
 
 
 
 
 
 
 

Summary 
Background: Total body weight loss (TBWL) after Bariatric Endoscopy (BE) is variable. 
Gastric emptying may be normal, rapid or delayed in patients with obesity and be a factor 
in variable BE outcomes. Gastric myoelectrical activity (GMA) reflects gastric 
pacemaker 
activity 
which 
controls 
gastric 
contractions. 
The 
non-invasive 
electrogastrogram (EGG) uses standard electrodes positioned on the abdominal surface 
to record GMA. There is currently a lack of studies in a population with obesity utilizing 
EGG to determine GMA patterns. We postulate that GMA patterns recorded with EGG  
will reflect subgroups in regards to stomach electrical physiology in obesity and that these 
subgroups will be useful in selecting patients for various BE procedures to maximize 
success of the procedures.  
Hypothesis: We postulate that GMA patterns recorded with Pre-intervention EGG can 
predict clinical success and adverse events after bariatric interventions. 
1.- INTRODUCTION 
1.1. Severe obesity as a health problem 
Obesity, defined as a body mass index (BMI) of 30 kg/m2, is increasing worldwide at 
alarming rates and is a cause of comorbidity and death. Nearly 2.8 million people die each 
year from obesity and being overweight according to the World Health Organization. In  
developed countries, the prevalence is more than 25%, with a high load of chronic 
comorbidities (hypertension, diabetes, atherogenic dyslipidemia, sleep apnea syndrome, 
hepatic steatosis, osteoarthritis, cancer, etc. (1). 
In Europe it is known by the European Association for the Study of Obesity (EASO) that, 
in the last decade, in countries such as Spain 30% of its children population (7-11 years) 
was obese and that there was, respectively, a prevalence of overweight of more than 39% 
and 15% in adults between 25 and 60 years. This year the prevalence of overweight could 
amount to > 70% of the population and that of obesity, to > 40 and it is  worst after the 
lockdown because of covid-19 pandemic. Adulthood obesity prevalence forecasts (2010–
2030) predict that in 2020, 27% of men and 19% of women will be obese. By 2030, the 
model predicts that 36% of men and 21% of women will be obese (1). In addition, it is 
severe and morbid obesity that grows proportionately the most (with prevalence > 5-10 
% of the population) and the costs of this disease have a cost of almost 10% of the total 
health budget in the European Union. Thus, the  socio-health impact is greater since 
medical treatments, based on lifestyle changes, are less effective. In this scenario, 
bariatric techniques (endoscopic or surgical), at present is the only effective long-term 
treatment that can offer significant weight loss (> 15-20%) and a parallel reduction in 
associated comorbidities (2).  
More than 135 million individuals are obese in India. The prevalence of obesity and 
central obesity varies from 11.8% to 31.3% and 16.9% to 36.3% respectively.(36) The 
prevalence of obesity is higher among the urban population, higher socioeconomic status, 
and south India.(35) 
In addition to preventing the development of obesity it is necessary to individualize 
therapies for each obese patient by selecting the most appropriate BE treatment, based on 

gastric physiology as described below, in order to increase the likelihood of successful 
total body weight loss (TBWL) and maintenance.  
1.2. Bariatric Techniques:-  
Bariatric techniques can be divided into three categories: restrictive, malabsorptive and 
mixed. In the first one, the procedures can be surgical or endoscopic. Malabsorptive 
techniques act on gastric capacity and perform complex anatomical short circuits that aim 
to reduce body weight significantly in very obese patients (BMI < 45 kg/m2), at the 
expense of producing a "controlled malabsorption" picture of nutrients, vitamins and 
minerals. Gastric bypass has been the "gold-standard" technique in bariatric surgery for 
decades, due to its long-term efficacy and it combines a restrictive procedure with another 
maldigestive, allowing average weight loss of around 30%, without side effects of 
intestinal malabsorption. 
As a restrictive bariatric surgery technique, sleeve gastrectomy  is the procedure of choice 
today, which due to its relatively low technical difficulty and results close to those of 
gastric bypass, is displacing other surgical techniques at the international level. 
worldwide Technically, a gastric tubular reservoir is created guided by a Fouchet 
orogastric tube calibrated at 42 Fr (14 mm), sectioning the greater gastric curvature from 
6 cm proximal to the pylorus to the bottom. In this way the gastric volume is reduced by 
approximately 70-80%. This technique allows full maintenance of gastric functions, 
gastric emptying through the pylorus and without the need to act on the absorption of 
nutrients at the intestinal level. 
According to 2019 data from the International Federation for the Surgery of Obesity 
(IFSO), SG is the preferred technique used in Europe (43%), compared to gastric bypass 
(35%), which came in second place. In Spain, gastric bypass continues to occupy first 
place (43%), compared to GV (34%), followed by biliopancreatic diversions (13.6%), 
mini-gastric bypass (6.2%), gastric band adjustable (1.1%) and gastric plication (0.9%). 
As for India in the year 2014, the percentage distribution of different procedures 
performed was 68% for LSG, 16% for LRYGB, and 14% for MGB-OAGB. In 2018, 48% 
of the procedures performed were LSG, while MGB-OAGB and LRYGB were at 34% 
and 15%, respectively.(37) 
 
Bariatric endoscopy (BE) techniques have emerged as safe and effective treatment that 
include restrictive endoscopic techniques: Intragastric balloons (IGB), endoscopic sleeve 
gastroplasty (ESG), primary surgery obesity endoluminal (POSE) or Endo-Sleeve (GESP 
or POSE 2.0) procedures; malabsorptive techniques: endoluminal bypass (endobarrier), 
duodenal mucosa resurfacing; extraction methods (Aspire); electrical stimulation: gastric 
pacemaker, vagal blockage and other procedures including botulinum toxin, magnetic 
compression anastomosis or the novel endozip (2, 3, 4,5,6).  
 
1.3. Gastric motility, electrogastrography, weight control and bariatric techniques 

Total body weight loss (TBWL) in response to these therapies is variable. The 
pathophysiological mechanisms involved behind bariatric techniques go beyond 
restrictive capacity and malabsorption secondary to anatomical changes caused by 
different therapeutic procedures that help explain the improvement of metabolic disorders 
(diabetes, insulin resistance, dyslipidemia, improvement of hepatic steatosis, etc.). even 
before weight loss has been clearly evident with cambios in the secretion and regulation 
profile of gastrointestinal hormones, bile acids, pro-inflammatory cytokine pattern, 
immune capacity, intestinal microbiota, etc (7). 
The combination of hormonal and gastric electrophysiological changes due to weight loss  
has physiological significance in light of the association between obesity and accelerated 
gastric emptying (GE) and the fact that GE delay of solids is an important determinant of 
fullness and satiety in humans  (8). 
 
The stomach is a complex neuromuscular organ that receives, mixes and empties ingested 
food. The neuromuscular work of the stomach is coordinated by the gastric pacemaker 
which controls the frequency and propagation of gastric peristaltic waves. For normal 
emptying of liquids and solids from the stomach into the duodenum integrated 
coordination of corpus-antral-pyloric contractions are required. 
 
There are neurogenic factors (parasympathetic afferents -efferents, intrinsic gastric 
pacemaker function), hormonal and biochemical factors (cholecystite, gamma-
aminobutyric acid, ghrelin, etc.), all of which have feedback mechanisms that affect 
gastric motility. There are also anatomical factors such as structural alterations or 
inflammatory conditions that affect motility and here is remarkable the role of interstitial 
cells of Cajal (ICCs).  ICCs are the pacemaker cells and interface between enteric nerves 
and smooth muscle cells and the key to gastric motility.  ICCs create the rhythmic 3 cpm 
electrical conduction system that coordinates the three per minute gastric peristaltic 
waves that results in normal gastric emptying (9). 
  
Variable weight loss and intolerance of BE procedures are appreciated.  For this protocole 
we define Failure of BE methods when patient only obtain less than 25% of EWL after 6 
months  of BE, according to the Part 1 of the BAROS (Bariatric Analysis and Reporting 
Outcome System) scale adapted to endoscopic treatment (2) (Table 1).  
 
After  BIG placement,  patients present intolerance such vomit and abdominal pain  in 
70-90% of cases at the first week but these effects can be extended up to three weeks 
(18%) and removal of the balloon in 4% of patients (3). Gastric emptying measured by 
gastric scintigraphy breath test or stable isotope breath tests show that there are 
physiological predictors of intolerance and response to BIG placement (10).  Many 
studies show that patients after ESG at 6 months achieved a mean of 50% of EWL or 
more  with rate of severe adverse events around 2% , including pain or nausea requiring 
hospitalization, upper gastrointestinal bleeding and peri-gastric leak or fluid collection 
(11).  
After SEG…… 

…… 
 
    Table 1 . BAROS (BARIATRIC ANALYSIS AND REPORTING OUTCOME 
SYSTEM) ADAPTED TO BARIATRIC ENDOSCOPY 
 
 
 
Thus, a fuller understanding of gastric physiology before undertaking BE treatments may 
lead to better patient selection for each procedure.  
 
 An important aspect of gastric emptying and physiology is GMA which reflects the 
gastric pacemaker activity that coordinates gastric peristaltic contractions.  The GMA is 
measured with electrogastrography methods that will be used in this study. 
 
Electrogastrography is a non-invasive method of recording  GMA that is used to diagnose 
gastric dysrhythmias in patients with intractable chronic nausea and vomiting, 
gastroparesis and gastroesophageal reflux (15,16,17). Electrogastrography signals are 
recorded using standard EKG-type electrodes placed on the surface of the upper stomach. 
3CPM Company developed the first patented, non-invasive FDA-approved diagnostic 
device that records and displays the EGG signal  and provides analysis of the  GMA signal 
for clinical diagnosis. 
Gastric dysrhythmias (tachygastria, 3.7 to 10 cpm, bradygastria, 1.0-2.5 cpm) and mixed 
dysrhythmias (combinations of tachygastria and bradygastria) are recorded with 
electrogastrography (17,18,19). In addition, patients with gastroparesis may have normal 
(2.5 to 3.7 cpm) or hypernormal GMA.  These patients have antro-pyloro-duodenal 

outflow dysfunction and respond well to endoscopic or surgical  therapies (20).  The 
pattern(s) of GMA in response to the WLST in obese patients who will undergo BE 
procedures is unknown.  In addition, the volume of water ingested in 5 minutes during 
the WLST indicates gastric capacity or accommodation which may be an important 
variable in patient selection for BE.  Finally, in patients with functional dyspepsia or 
gastroparesis, symptoms induced by the WLST include nausea, fullness, bloating and 
pain and and are scored on a VAS.  These symptoms, if elicited in the obese patients, may 
also represent an important variable for patient selection (21, 22, 23). 
The position of the electrodes on the upper abdominal surface, skin preparation and  test 
meals influence the GMA recordings. Interestingly, neither age nor sex has a definitive 
impact on the parameters for in adults or children (24, 25, 26). 
Controversial findings on the correlation between EGG and GE have been reported in the 
literature. Different authors have said that a normal 3 cpm GMA may not predict normal 
GE and dysrhythmic GMA may be present in delayed GE but is also present in functional 
dyspepsia. Patients with delayed GE and abnormal EGG have more severe symptoms and 
more tachygastria in pre and post-prandial states than patients with normal GE. 80% of 
the non-obese population has normal EGG and 20% have variability  (27 28, 29, 30). 
There is only one preliminar study of GMA with WLST before BE techniques in obesity 
(31), but has not been studied in before and after BE procedures to determine subtypes of 
GMA and whether or not subtypes will predict successful bariatric outcomes. 
 
Therefore, we propose a study  to evaluate the GMA in response to the WLST in patients 
who have agreed to BE procedures.  We hypothesize that GMA patterns in response to 
the WLST, the volume of water ingested and the array of symptoms elicited will help to 
predict successful outcomes of the bariatric procedures and thus help with patient 
selection for these procedures.  
 
2.- WORKING HYPOTHESIS 
Weight loss and long-term maintenance may be conditioned by changes in GMA, as well 
as by anatomical modifications induced by the bariatric procedure. 
Since anatomical modifications of the stomach by the BE procedures are related to weight 
loss, our purpose is to determine whether different procedures to reduce gastric capacity 
will result in substantial changes in GMA and in the water load volume ingested. No 
studies that have studied obese population before and after such BE procedures are 
available.  
Therefore, an important question is whether obese patients have the GMA that is similar 
to those with functional dyspepsia and normal weight (32). Also, the usefulness of 
electrogastrography as a new tool to customize choice of Bariatric therapies by 
determining success or failure based on GMA and WLST results has not been studied.  
GMA measures the normal or depleted gastric ICCs and the WLST measures gastric 
capacity, objective measures that may be important to predict  success of Bariatric 
procedures and thus to help with patient selection to maximize efficacy and minimize side 
effects (32).  

Hypothesis Question: Pre-intervention EGG can predict clinical success and adverse 
events after bariatric interventions?. 
 
Demonstrate the usefulness of EGG meizuring the GMA by identifying subtypes with the 
Water Load Satiety Test (WLST) in obese adults to predict individual successful 
responses to BE treatments: Intragastric Balloon (IGB) placement and Apollo Endoscopic 
Sleeve Gastroplasty (ESG) method.  
Demonstrate the usefulness of EGG meizuring the GMA by identifying subtypes with the 
Water Load Satiety Test (WLST) in obese adults to predict individual successful 
responses to BE treatments: Intragastric Balloon (IGB) placement and Apollo Endoscopic 
Sleeve Gastroplasty (ESG) method 
 
3.- OBJECTIVES 
3.1.- Primary Objective –  
 . Pre-intervention EGG parameters and/or changes in EGG parameters 
(one/three months) after bariatric intervention can predict clinical success at 
the end the of follow up 
a. Pre-intervention EGG  parameters and/or changes in EGG parameters 
after the bariatric intervention can predict adverse events at the end of follow-
up. 
 
3.2. Secondary:     
a. Secondary Objective 
To predict suitable bariatric intervention for patients depending upon a pre-
intervention EGG. 
b. EGG is a feasible diagnostic tool in obese population with reproducible and 
predictible results 
  
 
 
4.- STUDY DESIGN AND METHODOLOGY 
4.1. Type of study:  Multicenter,prospective, observational study in patients with body 
mass index (BMI)  at  30 kg/m2 prior and after one, and three, six and 12 months of an 
bariatric procedure. All tests will be analyzed by one blinded specialist.  
4.2. Study design: This is a pilot study, involving 2 hospitals in Spain and India, , where 
4 groups of patients will be recruited.  
a) Group of 50 patients who will undergo BIG placement 
b) Group of 50 patients who will undergo Endoscopic Sleeve Gastroplasty (ESG)  
Apollo method. 
c) Group of 50 patients who will undergo Surgical Sleeve Gastrectomy (SEG)  
Apollo method 

d) Group of 50 patients who will undergo RYGB method 
The protocol will be carried out in the run-up to the BE procedure until 12 months after 
of follow up. As a control group, 50 people (of the same age and gender) will be selected, 
with BMI less than 25%   who voluntarily agree to participate in the protocol and have 
the same criteria of inclusion or exclusion of patients that belongs to all the groups, except 
BMI.  
Duration – 18 months to 24 months 
 
4.3. Characteristics of subjects: 
Voluntary  patients with obesity will be recruited among those patients who will be 
given any of the four types of bariatric procedures described above, at the time before 
and after the first, third, sixth and 12 months of performing the bariatric methods. 
Patients will be recruited in AIG Hospitals, Gachibowli, Hyderabad 
Inclusion criteria: 
     1. Men and women, aged between 18-65 yrs 
     2. IMC basal ≥ 30 kg/m2 
     3. Patient undergoing bariatric intervention willing to participate in the study 
     4. Informed consent (oral and written) for the tests to be carried out. 
Exclusion criteria: 
1. Presence of severe cardiac, renal, hepatic, or neurological disease 
2. Long term use of medication that alter gastric motility (> 4 weeks) 
3. Significant alcohol or opioids or narcotics or tobacco 
4. Active malignancy 
5. Pregnancy 
6. Uncontrolled Diabetes Mellitus with glycosylated hemoglobin (HbA1c) levels ≥ 
6.5% or glucose level more than 270 mg/dL.  
7. Uncontrolled hypothyroidism (High TSH with low levels of Free T4)  
 
4.4. Collection of data and variables to be studied 
Anamnesis: Collection of clinical data in the medical history: history of obesity, evolution 
of weight, associated comorbidities, personal and family history. Dietary history. 
Anthropometric data: Weight, size, waist circumference, BMI. 
Electrogastrography data:  clínical diagnosis, percentage distribution, ratios 
4.5. EGG registration 

Instruments: The 3CPM electrogastrography device  will be used to record GMA  before 
and after  the WLST to record GMA.  3CPM EGGSAS GMAT Threshold software will 
be used for signal analysis. The data will be collected prospectively in a virtual log for 
blind analysis. (Figure 1) 
 
 
 
 
Figure 1 
 
On the morning of the EGG and water load satiety test, the subject will arrive fasting after 
midnight. Participants may take their usual medications  (e.g antihypertensive 
medications) with a small amount of water (up to 4 oz) up to two hours prior to the study, 
but should refrain from coffee, tea, or juice.  
At home, the skin of the abdomen should be shaved before for better placement of the 
electrodes.  The typical recording process usually takes a total of 1 hour: A 15 minutes 
baseline recording, 5 minutes of ingestion of water until “completely full,  and a 30 min 
post-ingestion recording.  
Electrogastrographic signals are recorded from electrodes placed  in the midline  midway 
between the xiphoid appendage and the umbilicus.  The  other  electrodes are placed in 
the  left  and right upper quadrant, respectively, from a straight line from  the midpoint of 
the clavicle and a point 2-3  cm below the left and right -costal border.  The belt to record 
respiration rate is placed above nipples of the chest level and is firmly fixed.   
Patients  should be seated in a comfortable chair, reclining at about 30-45 degrees and 
will remain motion-free throughout the test (Fig.2.3).  
 

 
                      
 
Figure 2 
  
 
             
 
 
 
Figure 3 
 
 
A 15 min baseline EGG recording is obtained and then the WLST is given. 
 
Water at from a tap is placed into a 1-liter container from which the patient will drink as 
directed below. The patient must be given the following instruction about the WLST in 
precisely the words below: 
 
Diabetic participants’ blood glucose level should be checked to ensure it is less than 270 
mg/dL. If the participant’s blood glucose level is greater than 270 mg/dL, it is either 
treated and rechecked before proceeding or the EGG and water load satiety test will be 
rescheduled for another day under better glucose control.  
Baseline symptoms prior to EGG recording are obtained using 100 mm visual analog 
scales (VAS) for stomach fullness, hunger, nausea, bloating, and abdominal discomfort. 
The patient marks each symptom line with a vertical line to indicate how they currently 
feel in terms of that symptom. Once the EGG and respiratory signals are stable, the 
baseline EGG recording period can begin.  
After the 15 min baseline EGG recording is completeds the participants will begin the 
Water Load Satiety Test. For this, participants will sit upright. During the test, participants 

will drink cool water from the 1 liter container (Figure 4). They will drink for a 5-minute 
period only and until they feel "completely full."  
 
          Figure 4 
A continuous 30 minute EGG recording is then obtained after the water is consumed. The 
participant's symptoms are recorded using VAS at 10, 20, and 30 minutes after ingestion 
of the water (at the end of the 0-10 minute, 11-20 minute, and the 21-30 minute periods 
after the water load ingestion) (Figure 5). The test is completed after the 30-minute 
recording period and the electrodes are removed). 
                    Figure 5.- Water Load Stress Test and Visual Analogue Scale  
 
It is important that the research associate at each site gives each subject the very 
same instructions as follows:   
“I want you to drink water from this container until you feel completely full. You have 
up to five minutes to reach the feeling of completely full. You may stop at any time, up 
to the five-minute time limit, when you feel completely full. This is not a test to see how 
much you can drink, but to drink until you are completely full in the five minute period.  
Do you have any questions about this?”  
*The total volume of water consumed will be recorded. 
4.7. EGG signal analysis 
EGG signal is reviewed for movement artifacts.  Artifact – free minutes  are chosen for 
blinded  computer analysis (at baseline, three, six and 12 months recordings and for each 
type of BE procedure). The selected minutes of EGG  are analyzed by spectral analysis 

by computer applications. 3CPM EGGSAS GMAT Threshold software will be used for 
signal analysis.  EGG data will be organized by clinical diagnosis.  Water load volumes 
ingested that are <238 ml are considered abnormally low (33).  
 
5.- STATISTIC 
The normal distribution of the variables will be confirmed by the kolmogorov-Smirnoff 
test. Quantitative variables shall be expressed as mean s/e d or means (interquartile range). 
Comparison between groups will be performed by parametric or nonparametric tests, 
depending on the distribution of the variables. Spearman or Pearson correlation will be 
used for the study of correlations. The possibility of multivariate logistic regression 
analysis will be explored. An SPSS statistical programme will be used.  EGG data will 
descriptive in terms of overall clinical EGG diagnosis and normal or abnormal water load 
volume ingested.  Symptom data before and after the WLST will be tabulated. These 
measures will be calculated before and 3 and 6 months after the BE procedures. 
 
6.- STUDY LIMITATIONS 
Recruitment of the number of subjects should not be a problem due to the high number 
of patients performed in the different centers and will allow the selection of those with 
the most approximate clinical results between groups. 
A strength of the study is to have a control group of non-obese subjects, which will allow 
us to know the normal pattern of GMA in response to the WLST and whether it is similar 
to those worldwide reported in healthy individuals. 
All tests will be carried out by the same expert operator in the medical center  and 
analyzed by one specialist in EGG that received the blinded information from all the 
centers  because it is a multicenter study, but the bariatric procedures will be performed 
by different operators from every center. 
 
 
 
7.- STAGES OF DEVELOPMENT AND DISTRIBUTION OF THE AREAS OF 
ALL RESEARCH EQUIPMENT 
The clinical study will be conducted simultaneously in AIG hospitals, Hyderabad,India.  
and Gastrodex, Dexeus University Hospital center in Spain.  The task layout of the study 
team members will be as follows: 
Eduardo Espinet-Coll (Coordinator of Digestive and Bariatric Endoscopy Unit at 
Gastrodex, Dexeus University Hospital) 

Director General and Coordinator of the study at the Dexeus Hospital, patient monitoring 
and responsible for performing BE techniques (IGB, endoscopic gastroplasty), dta 
analysis and participation in the drafting of research articles. 
 
Carmen Bautista-Altamirano (Gastroenterologist, researcher. Digestive and 
Bariatric Endoscopy Unit at Gastrodex, Dexeus University Hospital Medical 
university) 
General Coordinator: Responsible for Inter-hospital coordination and supervision of 
patients selection, compliance with patient indications, water-load stimulation test, data 
collection, monitoring, coordination of EGG registration. Blinded interpretation of 
results, participation in the drafting of research articles.  
 
Rakesh Kalapala (Director of Endoscopy, Bariatric and Metabolic Therapy at AIG 
Hospitals India ). 
Principal Investigator of the study at AIG Hospitals India, patient recruitment, responsible 
for performing BE techniques (IGB, endoscopic gastroplasty) and participation in the 
drafting of research articles. 
 
Nitin Jagtap (Senior Consultant Interventional Endoscopy at Asian Institute at 
Gastroenterology, India) 
Co- Investigator  of the study at Asian Institute of gastroenterology India, patient 
recruitment, responsible for performing Bariatric techniques (IGB, ESG, SEG) and 
participation in the drafting of research articles. 
 
Neeraj Singla (Senior Consultant, Interventional Endoscopy and GI motility at AIG 
Hospitals, India) 
Co- Investigator   of the study at AIG Hospitals India Medical center, patient recruitment, 
responsible for performing bariatric techniques (IGB, ESG and SEG) and participation in 
the drafting of research articles. 
 
David Mark Noar (Gastroenterologist at John Hopkins University Hospital 
Maryland, USA)  
Supplier of 3CPM electrogastrography and 3CPM EGGSAS GMAT Threshold software. 
Responsible for validating the blinded Interpretation results of EGG studies. 
Ajit Kolatkar (Director, GastroLab India Pvt Ltd, India) 

Co-ordinator and Supplier of 3CPM electrogastrography and 3CPM EGGSAS GMAT 
Threshold software. Responsible for validation and blinded Interpretation results of EGG 
studies. 
 
8.- STUDY EXECUTION TIME 
Considering that this is a prospective study with a predetermined number of non-high 
subjects, an execution time - from the baseline EGG, at three and six  months post-
procedure - is foreseen or approximately 18 months after the approval of the Ethics 
Committees Corresponding. In another 3 months, statistical analysis, interpretation of 
results and writing of the manuscript will be carried out. 
 
 
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