Use of a New Stapling Device in General Thoracic Surgery
Conditions: Thoracic Cancer
Sponsor: Lexington Medical Inc.

 
 
Endostapler Study Protocol 
Endostapler04 
NCT 05143541 
November 30, 2022 
 
 
A proposed study using AEON™ Endostapler Handles and Reloads  
(Lexington Medical, Inc., Billerica, Massachusetts, United States of America) 
 
Principal Investigator 
Dr. André Dutly (Surgeon) 
Kantonsspital St.Gallen, Switzerland 
 
Co-Investigator(s): 
Dr. Alexandru Has (Surgeon) 
Kantonsspital St.Gallen, Switzerland 
 
 
 
 

OBJECTIVES 
The goal of this post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used 
in VATS or open lung resection surgery (lobectomy or wedge resection). Patients eligible will be over the 
age of 18 and undergoing planned lobectomy or wedge resection. The study will include 30 total 
consecutive patients that meet eligibility criteria. The procedures will be performed according to 
institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as 
postoperative care. Relevant data will be collected using the Case Report Form which should be filled out 
following each procedure by a member of the surgical or nursing team. 
 
Enrollment: 80 Subjects Meeting Inclusion/Exclusion Criteria 
 
Investigator Masking: None (Open Label) 
 
Device: 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 are CE certified per Certificate No. G1 
003029 0001 Rev. 00. The AEON™ Endostapler devices were cleared by the United States Food and Drug 
Administration (FDA) under the 510(k) process. Pertinent applications numbers are K171589 and 
K173443. 
The AEON™ Endostapler has previously been proven as safe and effective for bariatric surgery as 
presented by Cleveland Clinic at SAGES 2019. The AEON™ Endostapler also has been evaluated for 
superior hemostasis against the Ethicon stapler with research led by Dr. James Redmann, as referenced 
inclinicaltrials.gov:   
https://clinicaltrials.gov/ct2/show/NCT04149925?term=AEON+or+%27Lexington+medical%27&draw=2
&rank=1.  
This study aims to demonstrate safety and effectiveness for thoracic surgery.  
 
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 table contains the available AEON™ Endostapler Reloads as well as their specifications. The 
surgeon should read and follow the Instructions for Use and use their own clinical judgement when 
determining the 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 
Gray (Curved Tip) 
45 mm 
AESC45G 
2.0 mm 
0.75 mm 
12 mm 
White 
45mm 
AESR45T 
2.5mm 
1.0mm 
12mm 
White (Curved Tip) 
45 mm 
AESC45T 
2.5 mm 
1.0 mm 
12 mm 
White 
60mm 
AESR60T 
2.5mm 
1.0mm 
12mm 
Orange 
45mm 
AESR45R 
3.25mm 
1.5mm 
12mm 
Orange (Curved Tip) 
45mm 
AESC45R 
3.25mm 
1.5mm 
12mm 
Orange 
60mm 
AESR60R 
3.25mm 
1.5mm 
12mm 
Purple 
45mm 
AESR45P 
4.0mm 
1.8mm 
12mm 
Purple (Curved Tip) 
45mm 
AESC45P 
4.0mm 
1.8mm 
12mm 
Purple 
60mm 
AESR60P 
4.0mm 
1.8mm 
12mm 
Black 
60mm 
AESR60B 
5.0mm 
2.2mm 
15mm 

STUDY DESIGN 
Patients satisfying the inclusion and exclusion criteria will be consecutively evaluated. Enrollment will be 
contingent on meeting these criteria, and the use of the AEON™ Endostapler.  
 
Patient Inclusion and Exclusion Criteria: 
Inclusion Criteria: 
• 
Patients undergoing planned VATS or open lung resection surgery (lobectomy or wedge 
resection) 
Exclusion Criteria: 
• 
Active bacterial or fungal infection 
• 
Prior history of VATS or open lung surgery  
• 
Use of staple line reinforcement material (buttress) 
• 
Patients under the age of 18 on the date of the surgery 
• 
Any female patient who is pregnant 
• 
Scheduled concurrent surgical procedure other than lobectomy or wedge resection 
(central venous access - e.g., port placement, mediastinoscopy with lymph node 
sampling, and VATS lymphadenectomy are allowed) 
 
Primary Outcome Measure: 
• 
Incidence of reported device-related adverse events through 30-day post-operative 
evaluation period 
 
Secondary Outcome Measures: 
• 
Incidence of product malfunction during procedure 
 
METHODS 
The study will include 80 total procedures on consecutive patients which will be performed by either Dr. 
André Dutly or Dr. Alexandru Has using the AEON™ Endostapler.  
All patients will undergo the standard preoperative evaluation pathway.  
On the day of surgery, the surgeon will elect to use the AEON™ Endoscopic Stapler Reloads. The surgeon 
should read and follow the Instructions for Use and use their own clinical judgement when determining 
the appropriate products to use. If the reloads are used, and it is clinically appropriate, reloads from 
other manufacturers should not be used for that case. However, in the event of unavailability of a 
clinically appropriate AEON™ Endoscopic Stapler Reload, a similar reload from another manufacturer is 

allowed. At the end of each case, a member of the surgical or nursing team will fill out the Case Report 
Form. 
All typical post-operative care will continue, including during the immediate post-operative period prior 
to hospital discharge. Regularly scheduled follow up appointments will be scheduled based on the 
preference and practice pattern of the surgeon and institution. 
 
Surgery Locations: 
Surgeries will all take place at Kantonsspital St. Gallen (Rorschacher Str. 95, 9001 St. Gallen, Switzerland). 
 
Statistical Analysis Plan:  
This is an open-label study. 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. Mean and standard 
deviation will be used for continuous data. 
 

Appendix A – Case Report Form 
Surgery Date: 
 
Surgeon: 
 
Hospital:  
 
Surgery Type:  
 
Patient Gender: 
 
Patient Age: 
 
 
AEON Endostapler 
Black 
60mm 
Purple 
60mm 
Purple 
45mm 
Orange 
60mm 
Orange 
45mm 
White 
60mm 
White 
45mm 
Gray 
45mm 
Quantity Non-Curved Tip 
Reloads Used 
 
 
 
 
 
 
 
 
Quantity Curved Tip 
Reloads Used 
 
 
 
 
 
 
 
 
 
Intraoperative Outcomes 
Product malfunction during stapling? (circle one) 
Yes 
No 
Blood transfusion due to staple line bleeding? (circle one) 
Yes 
No 
If yes to any above, please specify: 
 
 
 
 
 
30 Day Postoperative Outcomes 
Reported device-related adverse events? (circle one) 
Yes 
No 
If yes to any above, please specify: 
 
 
 
 
 
 
 
 
 
 
Investigator Signature:  
Date: