A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy
Conditions: Obesity
Sponsor: Lexington Medical Inc.

 
 
Endostapler Study Protocol 
July 28, 2020 
 
A proposed study using AEON™ Endostapler Handles and Reloads  
(Lexington Medical, Inc., Billerica, Massachusetts) 
 
Principal Investigator: 
Dr. Yannis Raftopoulos (surgeon) 
Weight Management program, Holyoke Medical Center, Holyoke, Massachusetts 
 
Research Coordinator: 
Elana Davidson 
 
Primary Outcome Evaluator: 
Dr. Pavlos Papasavas (surgeon) 
Hartford Hospital, Hartford, Connecticut 
 
 

SUMMARY 
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for 
laparoscopic bariatric surgery against the Endo GIA™ Reloads with Tri-Staple™ Technology from 
Medtronic. Stapler performance will be evaluated primarily by incidence and degree of staple line 
bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total 
consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG 
procedure will be performed according to institutional standard-of-care and all subjects will undergo 
standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the 
Data Collection sheet which should be filled out following each procedure by a member of the surgical or 
nursing team. 
 
Enrollment: 60 Subjects Meeting Inclusion/Exclusion Criteria 
 
Investigator Masking: None (Open Label) 
 
Primary Outcome Evaluator Masking: Yes (Surgeon and Device) 
 
Devices: AEON™ Endostapler and Endo GIA™ Reloads with Tri-Staple™ Technology and Ultra Universal 
Handle 
 
 
 

BACKGROUND 
The AEON™ Endostapler is comprised of a stapler handle and reloads. The handle may accept multiple 
reloads of single fire cartridges. The AEON™ Endostapler devices were approved by the United States Food 
and Drug Administration (FDA) under the 510(k) process. Pertinent applications numbers are K171589 
and K173443. Devices will be used pursuant to the indications specified in K171589 and K173443, as well 
as the general guidelines for use of this device on a prescription basis as outlined by the Federal Food, 
Drug, and Cosmetic Act (1976), and the Code of Federal Regulations Title 21 Part 800-895. 
 
Approved Indications for Use 
The AEON™ Endostapler has applications in general, abdominal, gynecologic, pediatric and thoracic 
surgery for resection, transection and creation of anastomoses. 
 
Available AEON™ Endostapler Reloads 
The following two tables contain the available AEON™ Endostapler Reloads, as well as the similar products 
that they may replace. This is meant as a guide, and the surgeon should read and follow the Instructions 
for Use and use their own clinical judgment to determine appropriate products to use. 
Table 1. Available AEON™ Endostapler Reloads 
Reload Type 
Cartridge 
Length 
Product 
Code 
Open Staple 
Height 
Closed 
Staple 
Height 
Minimum 
Port Size 
Gray 
45mm 
AESR45G 
2.0mm 
0.75mm 
12mm 
White 
45mm 
AESR45W 
2.5mm 
1.0mm 
12mm 
White 
60mm 
AESR60W 
2.5mm 
1.0mm 
12mm 
Orange 
45mm 
AESR45R 
3.25mm 
1.5mm 
12mm 
Orange 
60mm 
AESR60R 
3.25mm 
1.5mm 
12mm 
Purple 
45mm 
AESR45P 
4.0mm 
1.8mm 
12mm 
Purple 
60mm 
AESR60P 
4.0mm 
1.8mm 
12mm 
Black 
60mm 
AESR60B 
5.0mm 
2.2mm 
15mm 
 
Table 2. Approximate Equivalence for AEON™ Endostapler Reloads 
AEON™ Endostapler 
Endo GIA™ with Tri-Staple™ Technology 
Cartridge 
Color 
Open Staple 
Height (mm) 
Closed 
Staple 
Height (mm) 
Cartridge 
Color 
Open Staple 
Height (mm) 
Closed 
Staple 
Height (mm) 
Gray 
2.0 
0.75 
Gray 
2.0 
0.75 
White 
2.5 
1.0 
Tan 
2.0-3.0 
0.75-1.25 
Orange 
3.25 
1.5 
Purple 
3.0-4.0 
1.25-1.75 
Purple 
4.0 
1.8 
Purple 
3.0-4.0 
1.25-1.75 
Black 
5.0 
2.2 
Black 
4.0-5.0 
1.75-2.25 
 
 
 

STUDY DETAILS 
Patients will be screened based on the inclusion and exclusion criteria below and will be consecutively 
evaluated for study enrollment. Each case will be randomly assigned to one of the two FDA approved 
endoscopic staplers. For the purposes of this study, the surgeons will either use the AEON™ Endostapler 
or the Endo GIA™ Reloads with Tri-Staple™ Technology and Ultra Universal Handle from Medtronic. 
Enrollment will be contingent on meeting these criteria, and the use of either the AEON™ Endostapler or 
the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic. Study participation will begin once 
the subject signs the consent form and will end after the one-month postoperative follow up visit. 
 
Selection of Subjects: 
Inclusion Criteria 
• 
Patients undergoing planned laparoscopic sleeve gastrectomy 
• 
Informed consent for study obtained and signed from each subject 
Exclusion Criteria 
• 
Planned open surgical approach 
• 
Use of staple line reinforcement material (buttress) 
• 
Revision or other bariatric procedure 
• 
Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or PTT > 
45sec, or PT> 15sec, or INR>1.5  
• 
Patients with active HIV or Hepatitis B 
• 
Patients under the age of 18 on the date of the surgery 
• 
Patients who are pregnant 
• 
Patients using tobacco products within the last 2 weeks prior to surgery date 
• 
Patients using cortisone or related products within the last 2 weeks prior to surgery date 
 
Withdrawal of Subjects: 
Subjects are free to withdraw from the study at any time for any reason. Every effort will be made to 
determine why any subject withdraws from the study prematurely and this information will be recorded 
in the Clinical Study Report.  
In addition, subjects may be withdrawn from the study by the Principal Investigator in consultation with 
the Sponsor for the following reasons: 
• 
Adverse event 
• 
Protocol violation 
• 
Loss to follow-up  
If a subject withdraws prematurely, all data normally collected by study completion should be collected 
at the time of premature discontinuation or at the scheduled discharge. All subjects who withdraw from 

the study with an ongoing adverse event must be followed until the event is resolved or deemed stable. 
At the discretion of the PI, additional follow up visits may be done for subject safety. 
Withdrawn subjects will be replaced, until 60 subjects complete the study.  
 
Primary Outcome Measure: 
• 
Incidence of intraoperative staple line bleeding from endoscopic or laparoscopic images 
as measured by the provided bleeding severity scale 
 
Secondary Outcome Measures: 
• 
Incidence of postoperative leakage requiring intervention through 30-day post-
operative evaluation period 
• 
Incidence of intraoperative or postoperative blood transfusion within 72 hours of 
surgery start time 
• 
Hemoglobin difference between preop hemoglobin and hemoglobin on postoperative 
day #1 as well as difference between hemoglobin at recovery room and postoperative 
day #1 
• 
Incidence of reported device-related adverse events through 30-day post-operative 
evaluation period 
• 
Incidence of product malfunction during stapling 
• 
Total hospitalization time 
• 
Postoperative pain level per standard protocol (0-10 VAS scale completed at Recovery 
room, 6hrs postop and 7am at POD#1)  
• 
Postoperative nausea presence (0-10 scale VAS completed at Recovery room, 6hrs 
postop and 7am at POD#1)  
• 
Incidence of vomiting: incidence (at least one per patient) per stapler group, total 
episodes per group and emesis material (bloody or non-bloody)  
• 
Correlation of number of reloads used and specimen lengths and maximum widths as 
measured by pathology examination 
• 
Correlation of reload color used with observed bleeding and patient’s stomach thickness 
by path exam 
• 
Correlation of outcome parameters with BMI, visceral fat, gender and age 
• 
Need for clipping the staple line prior to completion of the staple line 
 
 
 
 
 
 

Steps and Procedures: 
The study will include 60 total consecutive cases, randomized for stapler type: 30 with the AEON™ 
Endostapler and 30 with Endo GIA™ Reloads with Tri-Staple™ Technology. Surgeries will be performed by 
Dr. Yannis Raftopoulos.  
All patients will undergo the standard preoperative evaluation pathway. Patients must sign informed 
consent for the operation. 
All firings with the AEON™ Endostapler will be done with THICK MODE for the purposes of this study and 
shall conform to the AEON™ Instructions for Use. All firings with the Endo GIA™ Reloads with Tri-Staple™ 
Technology and Ultra Universal Handle should be done according to the Endo GIA™ Instructions for Use. 
To measure incidence and degree of staple line bleeding, a third-party blinded evaluator will be used. No 
sutures, cautery or clips shall be applied during stapling for staple line bleeding, unless required at 
surgeon’s discretion. Following the last firing, a member of the surgical or nursing team or the research 
coordinator present for the case will count 10 seconds and then capture images with the laparoscope. If 
bleeding from the staple line requires control prior to the last firing, an additional image should be 
captured before applying sutures, cautery, clips, etc. Five pictures will be obtained from each case: the 
pylorus, distal sleeve near the distal end of the staple line, mid-sleeve at the incisura angularis, proximal 
sleeve and GEJ near the proximal end of the staple line. These photographs will be sent by the research 
coordinator to the third-party evaluator either electronically or by mail. The third-party evaluator will be 
blinded to the device of each case. Upon receipt of photographs, the evaluator will evaluate staple line 
bleeding according to a provided Bleeding Severity Scale for Laparoscope Images (Appendix A) and record 
results in the Bleeding Severity Evaluation Sheet (Appendix E). 
At the end of each case, the surgical team will fill out the relevant sections of the Data Collection Sheet 
(Appendix C). 
Gastroscopy will be performed, per standard protocol, at the beginning of the case to suction all gastric 
contents and decompress the stomach as well at the completion of the sleeve gastrectomy. Evaluation 
for intraluminal bleeding will be performed at the last gastroscopy according to Appendix E. During the 
last gastroscopy, no suctioning of the gastric contents will be performed until evaluation for bleeding is 
made and pictures are obtained. The gastroscopy will be performed before any use of clipping at the 
staple line unless for circumstances judged by the surgeon to be medically necessary to do so before the 
endoscopy. These instances will also be recorded. Five pictures will be obtained from each case: the 
pylorus, distal sleeve near the distal end of the staple line, mid-sleeve at the incisura angularis, proximal 
sleeve and GEJ near the proximal end of the staple line. These photographs will also be sent to the third-
party evaluator for evaluation of staple line bleeding according to a provided Bleeding Severity Scale for 
Endoscope Images (Appendix B). Results will be recorded in the Bleeding Severity Evaluation Sheet 
(Appendix E). 
The determination of laparoscopic and endoscopic staple line bleeding will be based on the picture with 
the highest bleeding severity score for laparoscopic and endoscopic evaluation separately. Every effort 
will be made that all pictures prior to any suctioning of the staple line laparoscopically or endoscopically. 
All typical post-operative care will continue, including immediate post-operative care prior to hospital 
discharge as well as the standard post-operative evaluation. A hemoglobin level will be checked at the 

recovery room and at 5am on postoperative day #1 per standard protocol. This hemoglobin must be 
drawn from the upper extremity opposite from the one with the IV running fluids or at the same extremity 
with the IV running fluids but distal to the IV. For each post-operative period, a member of the surgical or 
nursing team will fill out the relevant sections of the Data Collection Sheet (Appendix C). 
There will be no follow up study data collected after this point, however the patients will continue the 
standard follow up regimen per the physician’s practice. 
 
Surgery Locations: 
Surgeries will take place at Holyoke Medical Center (575 Beech St, Holyoke, MA 01040). 
 
Termination of the Study: 
The Principal Investigator reserves the right to terminate the study in the interest of subject welfare. The 
Sponsor may terminate the study for administrative reasons. 
Should the study be terminated, all documentation pertaining to the study must be returned to the 
Sponsor.  Any actions required to assess or maintain study subject safety will continue as required, despite 
termination of the study by the Sponsor. 
 
Protocol Deviations: 
Deviations from the protocol will be assessed as “minor” or “major” in agreement with the Sponsor. 
Major deviations from the protocol may lead to the exclusion of a subject from data analysis and will be 
considered on a case-by-case basis. 
The Investigator will not deviate from this protocol for any reason without prior written approval from 
the Sponsor, except in cases of medical emergencies. The Investigator may deviate from the protocol 
without prior approval only when the change is necessary to eliminate an apparent immediate hazard to 
a subject.  In that event, the Investigator will notify the Sponsor immediately by phone, notify the IRB, 
and confirm notification to the Sponsor in writing within 5 working days after the change is 
implemented. 
 
Risks: 
There are no additional risks to the patients participating in the study other than the known risks of the 
chosen procedure the sleeve gastrectomy. These known risks will be explained to the participating 
patients through the standard consent used for this procedure. In addition, there are no known additional 
risks from the use of either stapler. Both staplers are FDA approved and the surgeon-investigator of this 
study as well as the OR staff is very familiar with both staplers and loads. The surgeon has used both 
staplers and loads extensively in the past (>20 bariatric cases) and he is past the learning curve for either 
one.  

Statistics: 
This is an open-label study (since the patient will be blinded and the evaluation for the primary outcome 
will be done by a third party blinded to the stapler used). Formal sample size calculations were not 
performed as the purpose of the study is to demonstrate non-inferiority. The number of subjects was 
chosen based on feasibility and is considered sufficient to meet the study objectives. 
Detailed methodology for summary and statistical analyses of the data collected in this study will be 
documented in the Clinical Study Report. T-test and chi-square test will be used for univariate analysis of 
continuous and categorical data respectively. Regression analysis may be used to identify the 
independent effect of several parameters on primary or secondary outcomes if there are statistically 
significant differences in univariate analysis. 
 
Direct Access to Source Data/Documents: 
The Principal Investigator will ensure that the Sponsor, IRB, and regulatory authorities will have direct 
access to all study sites, source data/documents, and reports for the purpose of monitoring and 
auditing. In the event that other study-related monitoring should be done by other parties, those parties 
will be required to sign a confidentiality agreement prior to any monitoring or auditing. 

Appendix A – Bleeding Severity Scale for Laparoscope Images 
 

Appendix B – Bleeding Severity Scale for Endoscope Images 
 
 
 
 

Appendix B – Bleeding Severity Scale for Endoscope Images (continued) 
  

Appendix C – Data Collection Sheet 
Surgery Date: 
 
Surgeon: 
 
Hospital:  
Stapler Type (Circle): 
AEON™ Endostapler 
Endo GIA™ with Tri-Staple™ Technology 
Patient Gender: 
 
Patient Age: 
 
Patient BMI: 
 
 
AEON™ Endostapler 
Black 
60mm 
Purple 
60mm 
Purple 
45mm 
Orange 
60mm 
Orange 
45mm 
White 
60mm 
White 
45mm 
Quantity Reloads Used 
 
 
 
 
 
 
 
 
Endo GIA™ with Tri-Staple™ Technology 
Black 
60mm 
Black 
45mm 
Purple 
60mm 
Purple 
45mm 
Tan 
60mm 
Tan 
45mm 
Quantity Reloads Used 
 
 
 
 
 
 
 
Intraoperative Outcomes 
Product malfunction during stapling? (circle one) 
Yes 
No 
Blood transfusion due to staple line bleeding? (circle one) 
Yes 
No 
Visceral fat: 
 
Clips required for bleeding (non-routine)? (circle one) 
Yes 
No 
If yes to any above, please specify: 
 
 
 
 
Postoperative Outcomes 
 
Pre-op 
Recovery 
6 Hours 
POD #1 
Pain level per standard protocol (0-10 VAS scale): 
N/A 
 
 
 
Nausea level per standard protocol (0-10 VAS scale): 
N/A 
 
 
 
Hemoglobin: 
 
 
N/A 
 
72 Hours 
Blood transfusion due to staple line bleeding? (circle one) 
Yes 
No 
30 Days 
Total hospitalization time: 
 
Number of vomiting episodes: 
 
Bloody 
Non-bloody 
Reported device-related adverse events? (circle one) 
Yes 
No 
Postoperative leakage requiring intervention? (circle one) 
Yes 
No 
If yes to any above, please specify: 
 
 
 
 

Appendix D – Pathology Exam Data Sheet 
Exam Date: 
 
Case #: 
 
 
Specimen Length: 
 
Maximum Width: 
 
Stomach Thickness:  
 
 
 

Appendix E – Bleeding Severity Evaluation Sheet 
Evaluation Date: 
 
Evaluator: 
 
 
Case 
# 
Staple Line Image 
from Laparoscope 
Staple line bleeding per Bleeding Severity Scale (choose one): 
No 
bleeding 
Minimal 
bleeding 
Moderate 
bleeding 
Excessive 
bleeding 
Profuse 
bleeding 
 
A. Pylorus   
1 
2 
3 
4 
5 
B. Distal sleeve near 
distal end 
1 
2 
3 
4 
5 
C. Distal sleeve 
1 
2 
3 
4 
5 
D. Proximal sleeve 
1 
2 
3 
4 
5 
E. GEJ near proximal 
end 
1 
2 
3 
4 
5 
 
Case 
# 
Staple Line Image 
from Endoscope 
Staple line bleeding per Bleeding Severity Scale (choose one): 
No 
bleeding 
Minimal 
bleeding 
Moderate 
bleeding 
Excessive 
bleeding 
Profuse 
bleeding 
 
F. Pylorus   
1 
2 
3 
4 
5 
G. Distal sleeve near 
distal end 
1 
2 
3 
4 
5 
H. Distal sleeve 
1 
2 
3 
4 
5 
I. Proximal sleeve 
1 
2 
3 
4 
5 
J. GEJ near proximal 
end 
1 
2 
3 
4 
5