Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
Conditions: Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Sponsor: Lexington Medical Inc.

 
 
Endostapler Hemostasis Study Protocol 
September 9, 2019 
 
A proposed study using AEON™ Endostapler Handles and Reloads  
(Lexington Medical, Inc., Billerica, Massachusetts) 
 
Principal Investigator: 
Dr. James Redmann (surgeon) 
 
Co-Investigator(s): 
Dr. Thomas Lavin (surgeon) 
Dr. Matthew French (surgeon) 
 
Research Coordinator: 
Jennifer Perilloux 
 
Primary Outcome Evaluator: 
Dr. Natan Zundel 
 
 

SUMMARY 
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler 
performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon 
Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence 
and degree of staple line bleeding through a third-party blinded primary outcome evaluator. 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 Echelon Flex™ Powered Stapler System 
 
 
 

LEXINGTON MEDICAL AEON™ ENDOSTAPLER 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 
Echelon Flex™ 
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 
White 
2.5 
1.0 
Orange 
3.25 
1.5 
Blue 
3.5 
1.5 
Purple 
4.0 
1.8 
Gold 
3.8 
1.8 
Purple 
4.0 
1.8 
Green 
4.1 
2.0 
Black 
5.0 
2.2 
Black 
4.2 
2.3 
 
 
 

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 Echelon Flex™ Powered Stapler system from Ethicon. Enrollment will be contingent on meeting 
these criteria, and the use of either the AEON™ Endostapler or the Echelon Flex™ Powered Stapler system 
from Ethicon. 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 with signed surgery 
consent form 
• 
Informed consent for study obtained and signed from each subject 
Exclusion Criteria 
• 
Planned open surgical approach 
• 
Prior bariatric operation (i.e. revisional bariatric surgery) 
• 
Use of staple line reinforcement material (buttress) 
• 
Patients taking anticoagulants 
• 
Patients under the age of 18 on the date of the surgery 
 
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 as measured by the provided bleeding 
severity scale 
 
Secondary Outcome Measures: 
• 
Incidence of postoperative leakage during one-month monitoring period following 
procedure 
• 
Incidence of reported device-related adverse events 
• 
Incidence of product malfunction during procedure 
• 
Incidence of intraoperative or postoperative blood transfusion within 72 hours of 
surgery start time 
• 
Postoperative pain level per standard protocol 
 
Steps and Procedures: 
The study will include 60 total consecutive cases, randomized for stapler type: 30 with the AEON™ 
Endostapler and 30 with Echelon Flex™. Surgeries will be performed by either Dr. James Redmann, Dr. 
Thomas Lavin, or Dr. Matthew French, with at least 5 surgeries of each stapler brand per surgeon.  
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 EASY/THICK MODE for the purposes of this study 
and shall conform to the AEON™ Instructions For Use (Appendix C). All firings with the Echelon Flex™ 
should be done according to the Echelon Flex™ Instructions for Use. 
In order to measure the primary outcome of incidence and degree of staple line bleeding, a third-party 
blinded primary outcome evaluator will be used. No sutures, cautery or clips shall be applied to the staple 
line during stapling, 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 an image with the laparoscope. The visual should be clear and portray the entire length of the 
staple line. In the event that bleeding from the staple line requires control prior to the last firing, an 
additional image should be captured before applying sutures, cautery, clips, etc. These photographs will 
then be sent by the research coordinator to the primary outcome evaluator either electronically or by 
mail. The primary outcome evaluator will be blinded to both the surgeon and device of each case. Upon 
receipt of photographs, the evaluator will evaluate staple line bleeding according to a provided bleeding 
severity scale and record results in the Bleeding Severity Evaluation Sheet (Appendix B). If a case has more 
than one image associated with it, the primary outcome evaluator will consider all images when selecting 
a bleeding severity level. 
At the end of each case, the surgical team will fill out the relevant sections of the Data Collection Sheet 
(Appendix A). Case ID is captured as day/month/year, followed by surgery count for the day – e.g. 071619A 
for the first surgery performed on July 16, 2019. 

All typical post-operative care will continue, including immediate post-operative care prior to hospital 
discharge as well as the standard one-week and one-month post-operative evaluation. At the end of both 
the one-week and one-month post-operative period, a member of the surgical or nursing team will fill out 
the relevant sections of the Data Collection Sheet. 
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 Southern Surgical Hospital (1700 Lindberg Dr, Slidell, LA 70458), Crescent City 
Surgical Centre (3017 Galleria Dr, Metairie, LA 70001), or Avala Hospital (67252 Industry Ln, Covington, LA 
70433). 
 
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. 
 
Statistics: 
This is an open-label study. Formal sample size calculations were not performed.  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. 

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 – Data Collection Sheet 
OR Date: 
 
Surgeon: 
 
Case ID (e.g. 071619A): 
 
Hospital: 
 
Stapler Type (Circle): 
AEON™ Endostapler 
Echelon Flex™ Powered Stapler System 
Patient Medications: 
 
Patient Gender: 
 
Patient Age: 
 
Patient BMI: 
 
 
AEON™ Endostapler 
Black 
60mm 
Purple 
60mm 
Purple 
45mm 
Orange 
60mm 
Orange 
45mm 
Tan 
60mm 
Tan 
45mm 
Quantity Reloads Used 
 
 
 
 
 
 
 
 
Echelon FLEX™ 
Black 
60mm 
Black 
45mm 
Green 
60mm 
Green 
45mm 
Gold 
60mm 
Gold 
45mm 
Blue 
60mm 
Blue 
45mm 
White 
60mm 
White 
45mm 
Quantity Reloads 
Used 
 
 
 
 
 
 
 
 
 
 
 
Intraoperative Outcomes 
Product malfunction (circle) 
Yes 
No 
N/A 
Blood transfusion due to staple line bleeding (circle) 
Yes 
No 
N/A 
 
Surgeon overall satisfaction 
with the stapler used (circle): 
Dissatisfied 
Somewhat 
dissatisfied 
Neutral 
Somewhat 
satisfied 
Satisfied 
 
Postoperative Outcomes 
Blood transfusion due to staple line bleeding within 72 
hours of surgery start time (circle) 
Yes 
No 
N/A 
1 Week 
Dysphagia present (circle) 
Yes 
No 
N/A 
Nausea present (circle) 
Yes 
No 
N/A 
Weight loss: 
 
Pain level per standard protocol: 
 
1 Month 
Postoperative leakage during one-month monitoring 
period following procedure (circle) 
Yes 
No 
N/A 
Reported device-related adverse events (circle) 
Yes 
No 
N/A 
If yes, please specify:  
 

Appendix B – Bleeding Severity Evaluation Sheet 
 
Evaluation Date: 
 
Evaluator: 
 
Case ID (e.g. 071619A): 
 
 
 
Staple line bleeding according to 
Bleeding Severity Scale (circle): 
1 
2 
3 
4 
5 
 
No 
bleeding 
Minimal 
bleeding 
Moderate 
bleeding 
Excessive 
bleeding 
Profuse 
bleeding