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| Name | Class |
|---|---|
| Surgical Specialists of Louisiana | OTHER |
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The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEON Endostapler | Stapling performed by AEON Endostapler |
| |
| Echelon Flex Powered Stapler | Stapling performed by Echelon Flex Powered Stapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEON Endostapler | Device | Surgery with AEON Endostapler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Staple Line Bleeding | Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding) | 10 seconds after last staple line |
| Measure | Description | Time Frame |
|---|---|---|
| Staple Line Leaking | Incidence of postoperative leakage during one-month monitoring period following procedure | 1 month following procedure |
| Adverse Events | Incidence of reported device-related adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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See above
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avala Hospital | Covington | Louisiana | 70433 | United States | ||
| Crescent City Surgical Centre |
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| ID | Title | Description |
|---|---|---|
| FG000 | AEON Endostapler | Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
| FG001 | Echelon Flex Powered Stapler | Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AEON Endostapler | Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
| BG001 | Echelon Flex Powered Stapler | Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Staple Line Bleeding | Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding) | Posted | Mean | Standard Deviation | score on a scale | 10 seconds after last staple line |
|
1 month
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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 | AEON Endostapler | Stapling performed by AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annette Dunn | Lexington Medical Inc. | 480-313-8505 | annette@lexington-med.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 12, 2019 | Feb 3, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2019 | Mar 17, 2020 | Prot_SAP_001.pdf |
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| Echelon Flex Powered Stapler |
| Device |
Surgery with Echelon Flex Powered Stapler |
|
| 1 month following procedure |
| Product Malfunction | Incidence of product malfunction during procedure | During surgery |
| Blood Transfusion | Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time | Within 72 hours of surgery start |
| Pain Level | Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain. | 1 week following procedure |
| Metairie |
| Louisiana |
| 70001 |
| United States |
| Southern Surgical Hospital | Slidell | Louisiana | 70458 | United States |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Staple Line Leaking | Incidence of postoperative leakage during one-month monitoring period following procedure | Posted | Count of Participants | Participants | 1 month following procedure |
|
|
|
| Secondary | Adverse Events | Incidence of reported device-related adverse events | Posted | Count of Participants | Participants | 1 month following procedure |
|
|
|
| Secondary | Product Malfunction | Incidence of product malfunction during procedure | Posted | Count of Participants | Participants | During surgery |
|
|
|
| Secondary | Blood Transfusion | Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time | Posted | Count of Participants | Participants | Within 72 hours of surgery start |
|
|
|
| Secondary | Pain Level | Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain. | Posted | Mean | Standard Deviation | score on a scale | 1 week following procedure |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Echelon Flex Powered Stapler | Stapling performed by Echelon Flex Powered Stapler Echelon Flex Powered Stapler: Surgery with Echelon Flex Powered Stapler | 0 | 30 | 0 | 30 | 0 | 30 |
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