Comparison Between Endoscopic vs. Suction Calibration System on Number of Staple Load Firings, Operative Duration, Cost, and Gastro-esophageal Reflux Disease Following Laparoscopic Sleeve Gastrectomy: is There a Difference
Phase: NA
Conditions: Gastrectomy, Obesity
Sponsor: Emory University

Protocol Title: Endoscopic vs. suction device calibration in sleeve gastrectomy 
 
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PROTOCOL TITLE:   Comparison between endoscopic vs. suction calibration system on 
number of staple load firings, operative duration, cost, and gastro-esophageal reflux 
disease following laparoscopic sleeve gastrectomy: is there a difference? 
 
 
PROTOCOL VERSION DATE: June 17, 2021 
 
 
NCT NUMBER: NCT03939819 
 
 
 

Protocol Title: Endoscopic vs. suction device calibration in sleeve gastrectomy 
 
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PROTOCOL TITLE:   Comparison between endoscopic vs. suction calibration system on 
number of staple load firings, operative duration, cost, and gastro-esophageal reflux 
disease following laparoscopic sleeve gastrectomy: is there a difference? 
 
PRINCIPAL INVESTIGATOR: 
Elizabeth M. Hechenbleikner, MD  
Assistant Professor of Surgery 
Division of General and GI Surgery 
Department of Surgery 
Emory University School of Medicine 
Telephone Number: 404-778-3712 
Email: elizabeth.hechenbleikner@emory.edu 
 
External (non-Emory) Collaborators: 
 
Kevin Klocek, BSBME, MBA 
VP, Marketing and Business Development 
Boehringer Laboratories, LLC 
 
Phoenixville, PA 19460 USA 
 
Allen A. Orr, BS  
Director of Clinical Research  
Boehringer Laboratories, LLC 
 
Phoenixville, PA 19460 USA 
 
Matt Robinson 
Boehringer Laboratories/ViSiGi device area rep  
 
Daniel V. Samarov, PhD 
Statistician, National Institute of Standards and Technology 
 
Gaithersburg, MD 20899-8980 
 
 
VERSION: 1.0, 06/17/2021 
 
FUNDING SOURCE: Boehringer Laboratories, LLC 

Protocol Title: Endoscopic vs. suction device calibration in sleeve gastrectomy 
 
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REVISION HISTORY 
Revision # 
Version 
Date 
Summary of Changes 
1 
6/16/2021 
Protocol revised to transfer/add study information to the 
latest IRB protocol template. Also added the use of 
DocuSign for remote consenting of patients. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents: 
 
 
1. 
Study Summary ............................................................................................................ 5 
2. 
Objectives ...................................................................... Error! Bookmark not defined. 
3. 
Background .................................................................... Error! Bookmark not defined. 
4. 
Study Intervention/Investigational Agent ..................... Error! Bookmark not defined. 
5. 
Procedures Involved ...................................................... Error! Bookmark not defined. 
6. 
Inclusion and Exclusion Criteria ................................................................................. 10 
7. 
Local Number of Participants .................................................................................... 10 
8. 
Recruitment Methods ............................................................................................... 10 
9. 
Risk to Participants .................................................................................................... 10 
10. 
Potential Benefits to Participants .......................................................................... 11 
11. 
Compensation to Participants ............................................................................... 11 
12. 
Data Management and Confidentiality ..................... Error! Bookmark not defined. 
13. 
Statistical Analysis .................................................................................................. 12 
14. 
Provisions to Monitor the Data to Ensure the Safety of Participants ................... 12 
15. 
Economic Burden to Participants .......................................................................... 14 
16. 
Informed Consent ...................................................... Error! Bookmark not defined. 
17. 
Setting ........................................................................ Error! Bookmark not defined. 
18. 
References ................................................................. Error! Bookmark not defined. 
 
 
 
 
 
 
 
 
 
 

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1. Study Summary 
Project Title 
Comparison between endoscopic vs. suction 
calibration system on number of staple load firings, 
operative duration, cost, and gastro-esophageal reflux 
disease following laparoscopic sleeve gastrectomy: is 
there a difference?  
Project Design 
Prospective, randomized, open-label, single center, 
investigator-initiated study 
Primary Objective 
To evaluate if there is a significant difference in the 
number of staple load firings required for endoscopic 
(EGD) vs. ViSiGi® 3D suction device for calibration 
during sleeve gastrectomy 
Secondary Objective(s) 
i. 
To evaluate if there is a significant difference in 
operative duration (time) and intra-operative cost for 
patients undergoing EGD vs. ViSiGi® 3D suction device 
calibration during sleeve gastrectomy  
ii. 
To assess longer post-operative outcomes 
including GERD symptom severity and weight loss 
Research 
Intervention(s)/Interactions 
Screening/Consenting - In person preoperatively or 
electronically Docusign Electronically 
 
Operative Day- GERD baseline questionnaire / Surgical 
Intervention 
 
2 months and 12 (+/- 12 months)  – GERD 
questionnaire completion via telephone by research 
personnel or in person visit scheduled 
Study Population 
Patients requiring gastric band sleeve surgery 
Sample Size 
The target enrollment will be 125 subjects 
Study Duration for 
individual participants 
12 months for all participants consented prior to 
05/10/2021 unless reconsented to latest version 
 
24 months for all participants consented after 
05/10/2021 or reconsented to latest version 
Study Specific 
Abbreviations/ Definitions  
BMI – Body Mass Index 
GERD - gastroesophageal reflux disease 
LSG - laparoscopic sleeve gastrectomy 
RB - rubber bougie 

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SCD - suction calibration device 
SG - sleeve gastrectomy 
Funding Source (if any) 
This is a physician-sponsored study. Boehringer will 
provide the ViSiGi devices at no charge. Anticipated 
funding for start-up costs may also be provided by 
Boehringer. Internal funds will support trial 
implementation and analyses. 
 
2. Objectives:  
Primary aim:  
i. Evaluate if there is a significant difference in the number of staple 
load firings required for endoscopic (EGD) vs. ViSiGi® 3D suction 
device for calibration during sleeve gastrectomy  
Secondary aims: 
ii. Evaluate if there is a significant difference in operative duration 
(time) and intra-operative cost for patients undergoing EGD vs. 
ViSiGi® 3D suction device calibration during sleeve gastrectomy  
iii. Assess longer post-operative outcomes including GERD symptom 
severity and weight loss 
1. GERD-HRQL questionnaire pre-op and post-op 2 (+/- 2 
months) & 12 mo (+/- 12 months) (4)  
2. Weight loss – mean % total body weight loss, mean % 
EWL, mean % change in BMI (12 mo, +/- 12 months) 
3. Background 
Previous studies have shown that compared to a standard weighted rubber bougie (RB), 
using a suction calibration device (SCD) results in a straighter staple line compared to a 
twisted and corkscrewed staple line (1); no studies to date have compared upper 
endoscopy calibration to SCD for SG.  Due to the straighter, and therefore shorter, 
staple line, the hypothesis is the surgeon should be able to use fewer staple loads with a 
SCD. Bariatric staple loads are expensive, so a reduction in their use has the potential for 
savings to the hospital.  
 
The study will also look at how a suction calibration system can create savings for the 
hospital in OR time and scope processing costs.  As previously mentioned, the SCD may 
require fewer stapler load firings; it also eliminates the need for placing multiple tubes 
in to the stomach as well as an upper endoscopy leak test and therefore saves the OR 
staff time and may decrease operative duration. The SCD is also disposable which 

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eliminates the need for reprocessing. Current estimates for reprocessing an endoscope 
are around $200 (2) thus the SCD use may decrease operative cost.   
 
It is also hypothesized that a misaligned smaller sleeve after a LSG procedure can 
increase the prevalence of post-operative GERD due to removal of the fundus and 
twisting of the sleeve (3). A straighter, correctly calibrated sleeve should decrease the 
prevalence of GERD in patients.  Therefore, the study will also look at the prevalence of 
pre-operative vs. post-operative GERD symptoms in patients who are undergoing LSG 
with endoscopic calibration vs. SCD.   
 
4. Study Intervention/Investigational Agent 
 
 
Pre-operative 
period & 
Bariatrical 
Surgical consult  
Day of Surgery 
(LSG) 
Immediate 
Post-op 
follow-up 
(3 weeks) 
(+/- 2 
weeks) 
2mo post 
op f/u (+/- 
2 months) 
12 mo post 
op f/u (+/- 
12 months) 
Attg Surgeon 
or  
Surgical 
house staff 
research 
team 
members 
Assess candidacy 
of patients for 
enrollment in 
study 
*Patients to be 
randomized into 
either EGD vs 
ViSiGi calibration 
sleeve 
gastrectomy 
*Pre-op 
education on 
ViSiGI usage via 
rep and online 
videos, 
instruction sheet 
for surgeons 
involved  
EGD  vs ViSiGi 
device usage for 
sleeve 
*No SPECIMEN 
COLLECTED 
*Standardize 
surgeon 
technique   
*Fill out 
Powernote 
template 
collecting all 
intraop data 
Assess for 
complicati
on & 
document 
in Exemplo   
*medical 
bariatricia
n f/u at 
2mo  
*obtain 
cost data 
  
Assess long-
term weight 
loss,  
Compile 
tables, 
figures etc 
for abstract 
and 
manuscript 
generation 
 
Study 
coordinator 
 
Enroll, research 
consent process, 
administer 
 
Ensure 
powernotes are 
 
 
GERD-
HRQL (in 
 
GERD-HRQL 
(in person 
or phone) 

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baseline GERD-
HRQL, notify data 
analyst  
*Save hard copy 
of consent, 
paperwork in 
MOT7 
done collection 
intraop data  
*notify data 
analyst  
person or 
phone) 
Data Analyst 
Enter patient as 
enrolled in 
Exemplo  data 
base along with 
PHI, 
demographics, 
etc.  
Enter OR date in 
Exemplo 
database along 
with operative 
duration and 
stapler 
information 
(HER op note, 
PowerNote with 
template for all 
pertinent data)  
Assess for 
complicati
on in EHR  
EHR 
review for 
any 30-
day post-
op issues, 
GERD data 
entry, 
enter cost 
data as 
able 
Query 
MBSAQIP 
for any 
post-op 
issues & 
weight loss 
data, enter 
GERD data 
entry, 
Assist w/ 
tables, 
figures etc 
for abstract 
and 
manuscript 
generation 
Statistician  
NA 
 
 
 
TBD 
 
5.  Procedures Involved 
• Pre-operative period & Bariatrical Surgical consult (usually 1-2 mo prior to 
surgery) period:  
o Assessing candidacy for study enrollment, research consent process, 
surgeon education on device, and GERD-HRQL for diagnostic and 
research purposes  
o Patients will be randomized to either the EGD vs. the ViSiGi device for 
sleeve gastrectomy calibration  
o Neither the surgeon nor patient will be blinded to the device used  
o Patients will find out if they are in the EGD vs. ViSiGi device group pre-
operatively  
 
• Day of surgery = Postop Day zero (POD0)  
o Use of EGD vs. ViSiGi calibration for sleeve intended for therapeutic and 
research purposes for surgeon 

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o Risks/discomforts of EGD and ViSiGi device are comparable.  Using a 
ViSiGi device is similar to both a standard weighted bougie and an EGD 
calibration technique.  The ViSiGi device is similar to a gastroscope in that 
they both have suction, calibration, and leak testing capabilities.   The 
benefit of the ViSiGi device is that it obviates the need for doing an EGD 
during sleeve gastrectomy, is single patient use and thus does not require 
reprocessing, and doesn’t require a scope tower to operate it.  Potential 
benefits of using the ViSiGi device (in lieu of endoscopic calibration) in 
order of highest probability are as follows: 1) less staple loads, 2) shorter 
OR time, 3) reduced cost, 4) decreased post-op GERD rates. 
o Data analyst and study coordinator to have research roles at this time 
 
• Immediate post-op follow-up 3 weeks after surgery (+/- 2 weeks) to 12 months 
out (+/- 12 months) 
o Assessments made by surgeon will be for diagnostic, therapeutic and 
research purposes as appropriate 
o Study coordinator and data analyst will function in research roles only  
o Goal in this period is predominantly research purposes only  
o Due to constraints from COVID-19 and decreased in-person follow-up, 
the 12-month assessment time frame will be extended to 24 months 
post-surgery to help gather GERD-HRQL and weight loss data  
a. What type of information will be collected:  
i. See above table  
ii. Demographic and clinical variables will be collected at (baseline) 
including age, gender, race, BMI, smoking status, functional 
status, and medical comorbidities:  
1. EHR 
2. MBSAQIP 
3. Baseline GERD-HRQL scores (standardized questionnaire) 
iii. Intra-operative/procedure data (i.e. type of stapler used, # staple 
load firings, length and color stapler loads, etc.) 
1. EHR 
2. Research data sheets  
iv. Post-operative data & assessment  
1. EHR 
2. MBSAQIP (30-day outcomes and weight loss outcomes) 
3. Cost data (administrative data) from internal databases 
4. GERD-HRQL scores (standardized questionnaire) 
 
 

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6. Inclusion and Exclusion Criteria 
Patients selected for this study will be adults, 18 years old or older, who have already 
agreed with their surgeon that LSG is the best choice for them.  Patients will be excluded 
by the following criteria;  
• Subjects with prior gastric surgery or bariatric surgery (including prior adjustable 
gastric band and/or sleeve gastrectomy).   
• Concomitant hiatal surgery 
• Paraesophageal hernia at time of surgery 
• Any subject with prescribed immunosuppressive drugs. 
• In the opinion of investigator, subject is not eligible to participate in the study. 
• If patient is a female and becomes pregnant at any time during the study 
duration  
 
7. Local Number of Participants 
There is no additional screening for the study that the patient would already be subject 
to if they were not part of the study. There will be 50 patients undergoing LSG with an 
endoscope and 50 patients undergoing LSG with a suction calibration system.  Patients 
will be assigned randomly to each group.   
8. Recruitment Methods 
9. Subjects will be identified by the 1) treating physician/surgeon and/or her 
clinical staff or 2) the study staff reviewing clinic and/or hospital admissions. 
Risk to Participants 
The risk for participating in this study is expected to be minimal and equivalent to 
standard peri-operative morbidity and mortality associated with sleeve gastrectomy. 
Moreover, patient safety and risk profiles are expected to be similar between the 
endoscopic vs. suction device calibration techniques.  A rare complication associated 
with laparoscopic bariatric is tube/probe stapling during sleeve gastrectomy.  Given that 
the ViSiGi device is a plastic tube it could potentially be stapled across during 
gastrectomy or cause other trauma to the stomach or esophagus with intra-operative 
manipulation during sleeve gastrectomy.  It is also possible for a gastroscope to be 
stapled across during gastrectomy and to cause mucosal trauma with manipulation and 
suctioning during sleeve gastrectomy.  Again, the overall risk directly associated with 
intra-operative use of either the ViSiGi or endoscopic devices during sleeve gastrectomy 
risk anticipated to be minimal (< 1%) and similar between groups.   
 

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10. Potential Benefits to Participants 
This study, by its nature, will be focusing on bariatric surgery and therefore people with 
obesity who meet standard NIH criteria for weight loss procedures like LSG (5). The 
information from this study may help the community by giving the hospital information 
on ways to more effectively and efficiently perform LSG. 
11. Compensation to Participants 
There will be no patient reimbursement for participation in this study. 
 
12. Data Management and Confidentiality 
Data for this study will be recorded on a secure password-protected electronic database 
called Exemplo.  Data entry will be done by study investigators and/or data analysts 
who are part of the approved IRB team.  Unidentified data may be shared with the 
sponsor, Boehringer Laboratories LLC.   
 
Data analysis will be done by internal or externally hired statisticians on de-identified 
data on spreadsheets downloaded from Exemplo.  
 
Separate intra-operative data will be collected from the EHR either via the Operative 
Note or via standardized PowerNote templates (if available) to help capture data 
pertinent during sleeve gastrectomy including the following:  
 
1) Patient Full Name: pre-populated/pull from eEMR 
2) MRN: pre-populated/pull from eEMR 
3) Date of surgery: pre-populated/pull from eEMR 
4) Primary Surgeon: pre-populated/pull from eEMR 
5) Stapler used: Echelon Flex Powered 60mm stapler, Endo GIA 60 mm Universal 
Stapler XL; Other (free text)  
6) Distance from pylorus for 1st stapler firing: Free text for centimeters   
7) Calibration device: EGD/Standard Weighted Bougie Tapered/Standard Weighted 
Bougie Blunt/ViSiGi device/Other (free text)  
8) Calibration device size: free text for French  
9) Total number of stapler load firings: free text number  
10) Length of stapler loads used (list number): 60 mm(free text number or click n/a); 
45 mm (free text number or click n/a); other (free text)  
11) Number, order & color of stapler loads (first to last; i.e. 2 green, 2 gold, 1 blue): 
free text  
12) Use of Seam Guard reinforcement for stapler loads: yes/no  
a. If yes, were all stapler loads reinforced? Yes/no; other (free text)  
13) Other procedures performed:  

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a. Plication/imbricating suture to sleeve: yes/no; other (free text) 
b. Pexy of omentum to sleeve: yes/no; other (free text) 
c. Clipping of sleeve staple line: yes/no; other (free text) 
d. Oversewing staple line: yes/no; other (free text) 
e. Fibrin glue to staple line: yes/no; other (free text) 
f. Any other procedures?: free  text  
14) EGD done: yes/no  
a. If yes, any abnormal findings: yes/no; other (free text) 
b. If abnormal findings, please list any interventions done: free text  
15) Miscellaneous Notes: free text  
 
 
13. Statistical Analysis 
There will be 50 patients undergoing LSG with an endoscope and 50 patients 
undergoing LSG with a suction calibration system.  Both methods are clinically 
accepted and approved methods of performing the procedure.  The target 
enrollment will be 125 to account for attrition due to screen failures, early 
withdrawals, etc. For this study we use a randomized block design (RBD) to assign 
participants to one of two sleeve groups. In a RBD we divide participants into 
subgroups called blocks (e.g. gender, race, etc.), such that the variability within 
blocks is less than the variability between blocks. Then, subjects within each block 
are randomly assigned to treatment conditions (i.e. SG with EGD or SG with ViSiGi 
device). The purpose of the RBD is to help reduce variability within treatment 
conditions and potential confounding from blocking factors, producing a better 
estimate of treatment effects.  We are adequately powered to detect a mean 
difference in stapler load firings of 0.4 between groups assuming a standard 
deviation of 0.7, which is consistent with our institutional sleeve gastrectomy 
experience.  After all cases have been performed statistical methods will be 
implemented to determine any difference in outcomes.  An initial approach will 
focus on a pairwise analysis (t-test) between the ViSiGi and EGD calibration groups 
for each of the primary and secondary aims.  A more comprehensive multivariate 
analysis factoring in demographic and clinical variables will be performed to further 
delineate significant differences in the 2 sleeve gastrectomy methods.  In the 
unlikely situation that an adverse event occurs, the event will be inspected to 
determine if an early stoppage is necessary. 
14. Provisions to Monitor the Data to Ensure the Safety of Participants 
All methods used in this study for performing sleeve gastrectomy are already approved 
and clinically accepted.  Validated users of the device will be attending surgeons who 
have been trained using the ViSiGi device via online video-based education 

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(https://www.youtube.com/watch?v=zDhc-1fr32E), review of the manufacturer 
instructions for use (IFU) sheet below: 
(chromeextension://oemmndcbldboiebfnladdacbdfmadadm/https://www.boehringerla
bs.com/wp-content/uploads/2018/09/5232009.pdf) as well as in-person education via 
representatives from Boehringer Laboratories, LLC.  
  
All surgeons will be required to complete the video-based module and review the IFU 
sheet prior to using the ViSiGi device. 
   
The PI will be responsible for ensuring participants’ safety on a weekly basis as cases are 
performed (sleeve gastrectomies are not always done every week) and for reporting 
serious Adverse Events (AEs) and Unanticipated Problems (UPs) to his or her 
Institutional Review Board (IRB) and the monitoring body with the help of the study 
coordinator. The study coordinator and/or PI will prepare reports that list AEs, serious 
AEs, deaths, and disease-or treatment-specific events required for MB review in order 
to ensure good clinical care and identify any concerning trends. The Monitoring Body 
(MB) will act in an advisory capacity to the PI to monitor participant safety, evaluate 
adverse events and progress of the study.  The MB will constitute two surgeons who are 
not directly involved in the study protocol but participate in the care of bariatric 
patients at Emory University Hospital Midtown and will to review the safety data 
annually.   
 
The PI will be informed of serious AEs as soon as they occur by Co-Investigators (i.e., 
surgeons performing sleeve gastrectomy) and/or the study coordinator and notify the 
MB within 48 hours of becoming aware of the event. The PI will report serious AEs and 
UPs to his or her IRB within 5 business days of becoming aware of the event. Events 
constituting UPs include calibration device malfunctions such as a piece or component 
of the device breaking off into the stomach during manipulation, failure of the device to 
adequately perform a leak test, or contamination or damage to the device such that it 
cannot be appropriately used.  Specific triggers for an ad hoc review or initiation of the 
process of an ad hoc review will occur if there are unforeseen deaths or if there is a 
serious AE including stapling across a calibration device during sleeve gastrectomy or 
other serious device malfunction leading to patient injury.  At any point during the study 
time period, the study will be stopped and undergo further review if ≥ 1 deaths or a 
serious AE directly related to calibration device use (i.e., stapling across device while 
creating sleeve gastrectomy or serious device malfunction leading to patient injury) 
occurs.   
 
Safety reports will be sent to the MB for review after the first 5 subjects are enrolled 
and within 12 months of the study start date.  Safety assessment reports will provide a 

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detailed analysis of safety issues including the incidence of AEs, clinical severity of AEs, 
serious AEs, UPs, deaths and protocol deviations.  The PI will also document receipt and 
review of these safety reports in addition to any corrective actions and/or resolutions to 
findings reported which will also be reported to the IRB.   
 
The sponsor does not have any additional reporting requirement than what Emory 
Hospital already has in place. 
15. Economic Burden to Participants 
N/A 
 
16. Informed Consent Process 
Consent will be obtained in person before the patient undergoes surgery by the 
principal investigator, co-investigators, and/or research study coordinator. Consent will 
likely occur at the initial surgical consultation, but may be obtained at any point prior to 
randomization. Patients will be notified if they are going to be in the EGD vs. ViSiGi 
device arm of the sleeve gastrectomy protocol during the perioperative  period; it will 
be explained to them that this selection is being done in a randomized fashion, similar 
to flipping a coin, factoring in various patient-related factors.  No elements of HIPAA will 
be waived. The study participants are legal adults and not pregnant, prisoners, or 
otherwise cognitively impaired in any way.   
 
DocuSign: 
The study team will use an Emory DocuSign account that is HIPAA compliant and meets 
the FDA’s requirement for CFR Part 11 signatures. The consent process begins when a 
patient is screened and identified as eligible for study participation. A member from the 
study team will discuss the informed consent form in its entirety with the potential 
participant via telephone phone and/or Zoom. The patient’s identity will be verified by 
requesting that he/she confirm their demographical information (i.e. full name, DOB, 
address, etc.).   
 
In DocuSign, potential subjects have the ability to review the consent document as 
freely as they would if they were consenting in person. They also have the opportunity 
to exit the document without signing. The patient will be offered ample time to discuss 
the informed consent form with family and or friends, and have questions answered. 
 
The process for obtaining final consent is outlined below: 
1. First, the IRB-approved, stamped informed consent form(s) are added to an 
envelope in DocuSign. 

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2. Secondly, recipients (subjects/coordinators) are then added to the envelope and 
signature and initial fields are assigned to them on the IRB approved informed 
consent form. 
3. Finally, once the document is completed, the signed copy is forwarded to the 
subject electronically via email. The completed informed consent form 
document is also saved on our secure internal shared drive. 
 
The signature area of the informed consent document has been updated to 
denote the subject’s electronic signature. 
 
17. Setting 
This study will be conducted at Emory University Hospital Midtown. 
18. References 
 
https://www.bostonscientific.com/content/dam/bostonscientific/uro-
wh/portfolio-group/LithoVue/pdfs/Sterilization-Resource-Handout.pdf 
 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4579881/ 
 
https://www.ncbi.nlm.nih.gov/pubmed/26169646 
 
https://www.niddk.nih.gov/health-information/weight-management/bariatric-
surgery/potential-candidatesVelanovich, V et al. Quality of life scale for 
gastroesophageal reflux disease.  J Am Coll Surg 1996; 183(3):217-224