Gastric Tissue Stapler Comparison Study

• Sponsor: Standard Bariatrics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04086433
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Resection	Device: gastric tissue resection

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Gastric Tissue Stapler Comparison Study
• Actual Study Start Date: Jul 15, 2019
• Actual Primary Completion Date: Oct 30, 2019
• Actual Study Completion Date: Oct 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Arm A - Echelon Stapler Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation	Device: gastric tissue resection; human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Arm B - Titan Stapler Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation	Device: gastric tissue resection; human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment

Outcome Measures

Primary Outcome Measures

1. Pressure Evaluation [immediately post operative]

   Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.

2. Staple Malformation [through study completion, anticipate within 2 months]

   Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University at Buffalo	Buffalo	New York	United States	14203

Sponsors and Collaborators

• Standard Bariatrics

Investigators

• Principal Investigator: Aaron B Hoffman, MD, FACS, University at Buffalo

Study Documents (Full-Text)

• Study Protocol - Jun 17, 2019

More Information

Publications

None provided.

• Responsible Party: Standard Bariatrics
• ClinicalTrials.gov Identifier: NCT04086433
• Other Study ID Numbers: CP-2018-01
• First Posted: Sep 11, 2019
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Arm A - Echelon Stapler	Arm B - Titan Stapler
Arm/Group Description	Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment	Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Period Title: Overall Study
STARTED	17	18
COMPLETED	17	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm A - Echelon Stapler	Arm B - Titan Stapler	Total
Arm/Group Description	Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment	Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment	Total of all reporting groups
Overall Participants	17	18	35
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	18 100%	35 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	41	46	44
Sex: Female, Male (Count of Participants)
Female	14 82.4%	13 72.2%	27 77.1%
Male	3 17.6%	5 27.8%	8 22.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	17 100%	18 100%	35 100%

Outcome Measures

1. Primary Outcome

Title	Pressure Evaluation
Description	Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded.
Time Frame	immediately post operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A - Echelon Stapler	Arm B - Titan Stapler
Arm/Group Description	Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment	Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
Measure Participants	17	18
Mean (Full Range) [mmHg]	126	163

2. Primary Outcome

Title	Staple Malformation
Description	Staple line specimen will be sent to an independent laboratory for imaging. Percentage of malformed staples in test staple line will be recorded by an independent assessor.
Time Frame	through study completion, anticipate within 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Not applicable. Investigation performed on excised tissue.
Adverse Event Reporting Description	Not applicable. Investigation performed on excised tissue.
Arm/Group Title	Arm A - Echelon Stapler		Arm B - Titan Stapler
Arm/Group Description	Excised gastric tissue specimens will be resected with the Echelon Stapler (Ethicon, size: 60mm, "Echelon") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment		Excised gastric tissue specimens will be resected with the Titan SGS Stapler (Standard Bariatrics, "Titan") and evaluated for burst pressure and staple malformation gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
All Cause Mortality
	Arm A - Echelon Stapler		Arm B - Titan Stapler
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Arm A - Echelon Stapler		Arm B - Titan Stapler
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Arm A - Echelon Stapler		Arm B - Titan Stapler
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Product Issues
Other	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.