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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gastric tissue resection | Device | human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pressure Evaluation | Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded. | immediately post operative |
| Staple Malformation | 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. | through study completion, anticipate within 2 months |
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Inclusion Criteria:
1. Laparoscopic sleeve gastrectomy patients at study site, ages 18 to 80
Exclusion Criteria:
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Subjects undergoing Laparoscopic Sleeve Gastrectomy
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| Name | Affiliation | Role |
|---|---|---|
| Aaron B Hoffman, MD, FACS | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
| FG001 | 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 gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pressure Evaluation | Burst pressure will be assessed in the specimen with one staple line (i.e. the test staple line) with a pressure volume curve recorded. | Posted | Mean | Full Range | mmHg | immediately post operative |
|
Not applicable. Investigation performed on excised tissue.
Not applicable. Investigation performed on excised tissue.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Product Issues | Systematic Assessment | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Sathe | Regulatory Mark | 5133047971 | alison@regulatorymark.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2019 | May 21, 2020 | Prot_000.pdf |
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| BG001 |
| 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 gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Staple Malformation | 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. | Not Posted | through study completion, anticipate within 2 months | Participants |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 gastric tissue resection: human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment | 0 | 0 | 0 | 0 | 0 | 0 |
|
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