Gastric Tissue Stapler Comparison Study

• ClinicalTrials.gov Identifier: NCT04086433
• Recruitment Status: Completed
• First Posted: September 11, 2019
• Results First Posted: June 5, 2020
• Last Update Posted: June 25, 2020
• Sponsor: Standard Bariatrics
• Information provided by (Responsible Party): Standard Bariatrics

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Condition: Gastric Resection
• Intervention: Device: gastric tissue resection
• Enrollment: 36

Participant Flow

Recruitment Details
Pre-assignment Details

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 Number of Baseline Participants		17	18	35
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	18 participants	35 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	17 100.0%	18 100.0%	35 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	17 participants	18 participants	35 participants
		41; (28 to 57)	46; (19 to 66)	44; (19 to 66)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants	18 participants	35 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 [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	17 participants	18 participants	35 participants
		17 100.0%	18 100.0%	35 100.0%

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
Overall Number of Participants Analyzed	17	18
Mean (Full Range); Unit of Measure: mmHg
	126; (46 to 226)	163; (82 to 259)

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 Not Reported

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 (%)	Affected / at Risk (%)
Total	0/0	0/0
Serious Adverse Events
	Arm A - Echelon Stapler	Arm B - Titan Stapler
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm A - Echelon Stapler	Arm B - Titan Stapler
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Product Issues
Other † [1]	0/0	0/0
† Indicates events were collected by systematic assessment; [1] All-cause mortality, serious and other adverse events were not monitored assessed. These are not applicable to this study because the study was performed on previously excised tissue.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Alison Sathe
• Organization: Regulatory Mark
• Phone: 5133047971
• EMail: alison@regulatorymark.com

• Responsible Party: Standard Bariatrics
• ClinicalTrials.gov Identifier: NCT04086433
• Other Study ID Numbers: CP-2018-01
• First Submitted: July 29, 2019
• First Posted: September 11, 2019
• Results First Submitted: May 21, 2020
• Results First Posted: June 5, 2020
• Last Update Posted: June 25, 2020