Gastric Tissue Stapler Comparison Study
Conditions: Gastric Resection
Sponsor: Standard Bariatrics

 
 
 
 
 
 
Title: Gastric Tissue Stapler Comparison Study  
Protocol Synopsis 
 
Protocol Number: CP-2018-01 
Principal Investigator: Aaron Hoffman MD, FACS  
Sponsor: Standard Bariatrics 
Revision: D 
June 17, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 

Gastric Tissue Stapler Comparison Study 
Revision D 
Protocol CP-2018-01 
June 17, 2019 
 
 
1 
STATEMENT OF COMPLIANCE 
 
The clinical study will be conducted according to the International Conference on Harmonization 
Good Clinical Practice (ICH GCP), which is applied to the United States (US) Code of Federal 
Regulations (CFR). A guarantee will be provided by Principal Investigator that the protocol will 
be conducted as written without deviations. The persons involved in conductance of this study 
understand ICH GCP Training and Human Subject Protection. 
 
All study documents including protocol, recruitment materials, participant material and informed 
consent form(s) will be submitted to the IRB authority for review and approval. The consent form 
and approval letter will be obtained prior to enrollment of participants. Any modification in the 
protocol will be sent for review and approval by the IRB prior to any change implementation in 
the study. Any change to the consent form will be reviewed and approved by the IRB; if the 
changes to the informed consent are made, a determination will be made if new consent will be 
required from participants who were given previous approved consent.  
 
PROTOCOL SUMMARY 
 
Title: 
 
Study Description: 
This study is conducted to compare performance characteristics of 
staple lines resecting the stomach in excised human gastric tissue 
with existing Echelon Flex Powered Plus GST System (Ethicon, size: 
60mm, “Echelon”) stapler and the Titan SGS (Standard Bariatrics, 
“Titan”). 
The Study is a single center clinical trial, randomized (1:1, Arm A - 
Ethicon Echelon 60 application, Arm B - Standard Bariatrics Titan 
SGS application) which utilizes the excised stomach tissue from up to 
75 adults undergoing laparoscopic sleeve gastrectomy (LSG). This 
study will be conducted in the USA. 
 
The following characteristics will be studied: 
1) Burst pressure and burst location in the test specimen  
2) Percentage of malformed staples  
 
 

Gastric Tissue Stapler Comparison Study 
Revision D 
Protocol CP-2018-01 
June 17, 2019 
 
 
2 
Objectives: 
 
Primary Objective:  
 
To obtain comparative data between the Echelon Stapler and the 
Titan Stapler in excised human stomach tissue for the following 
parameters: 
1) Burst pressure and burst location in the test specimen  
2) Percentage of malformed staples in test staple line 
 
 
Secondary Objectives:  
 
The following data will also be recorded: 
 
1) Tissue thickness and length along the original stomach 
resection line (i.e. measuring the length and thickness of the 
excised stomach specimen) 
2) Staple height (average, range, SD) 
3) Visual inspection and photographs of the staple lines 
4) Number of consecutive staple malformations per length of 
staple line; type of malform at each location and likelihood of 
leak path development. 
 
Study Population: 
  
This is an observational, non-intervention study. Only excised tissue 
will be tested. This study will include resected stomachs from the 
following population: 
  
Inclusion criteria: 
1. Laparoscopic sleeve gastrectomy patients at study site, ages 
18 to 80 
Exclusion criteria: 
1. Prior gastric surgery (lap band, Nissen fundoplication, G tube, 
greater curve plication, etc.)  
2. Gastric lesion recognized during surgery (entire specimen 
would be sent to pathology)  
3. Stomach damaged during extraction 
 
Description of Sites 
Enrolling Participants: 
1 site (USA), up to 75 subjects  
 
Description of Study: 
Both groups of the randomized trial will utilize the excised stomach 
(specimen) from patients of LSG. The specimen will be removed in 
a manner to preserve tissue integrity as described in the protocol. 

Gastric Tissue Stapler Comparison Study 
Revision D 
Protocol CP-2018-01 
June 17, 2019 
 
 
3 
The specimen will be immediate transferred to the onsite laboratory 
for examination and one additional resection with either the 
Echelon 60 mm stapler (Arm A) or the Titan stapler (Arm B).  
 
The specimen will first be examined for tissue integrity. If 
undamaged, the specimen will be measured and the length and 
thickness of the existing cut line on the specimen will be recorded 
using the Tissue Measuring Device (TMD).  
 
The test resection line will be placed 2 cm from the existing staple 
line with either the Echelon stapler (Arm A) or the Standard 
Bariatrics Titan SGS (Arm B). If Arm A, Echelon staple cartridges 
will be selected based on tissue thickness. After the resection of 
tissue is made, the following assessments will be conducted: 
 
• Visual inspection and photographs of the staple lines 
• Burst pressure and burst location will be assessed in 
the specimen with one staple line (i.e. the test staple 
line) with a pressure volume curve recorded.  
• 
The two-sided staple line specimen will be sent to an 
independent laboratory (Kinetic Vision, Cincinnati, 
OH) for imaging. Percentage of malformed staples in 
test staple line will be recorded by an independent 
assessor. Consecutive staple malformations will be 
recorded by the independent assessor. Well-formed 
staples will be measured and location cataloged.  
Study Duration: 
Q1 2019 to Q3 2019 (up to 39 weeks) 
 
Participant Duration: 
 
The patient-related activities of the trial are limited in duration and 
scope: 
• 
Screening for eligibility for enrolment (up to 2 visits over a maximum 
of 3 weeks) and consent 
• 
Removal of specimen during surgical procedure 
 
The remainder of study activities are conducted on the excised specimen 
and do not require subject involvement.