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The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEON Endostapler | Stapling performed with AEON Endostapler |
| |
| Endo GIA Reloads with Tri-Staple Technology | Stapling performed with Endo GIA Reloads with Tri-Staple Technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEON Endostapler | Device | Surgery with AEON Endostapler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Endoscopic Staple Line Bleeding Score | Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. | Within surgery, after the last stapler firing |
| Intraoperative Laparoscopic Staple Line Bleeding Score | Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. | Within surgery, images captured 10 seconds after the last stapler firing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Leakage Requiring Intervention | Number of participants with postoperative leakage requiring intervention | Within 30-day post-operative period |
| Number of Participants With Intraoperative or Postoperative Blood Transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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60 subjects
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holyoke Medical Center | Holyoke | Massachusetts | 01040 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AEON Endostapler | Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
| FG001 | Endo GIA Reloads With Tri-Staple Technology | Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AEON Endostapler | Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
| BG001 | Endo GIA Reloads With Tri-Staple Technology | Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology |
| 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 | Intraoperative Endoscopic Staple Line Bleeding Score | Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Within surgery, after the last stapler firing |
|
30 days
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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 with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bariatric Clinical Administrator | Holyoke Medical Center Weight Management Program | (413) 535 - 4759 | davidson_elana@holyokehealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2020 | Aug 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Endo GIA Reloads with Tri-Staple Technology |
| Device |
Surgery with Endo GIA Reloads with Tri-Staple Technology |
|
Number of participants with intraoperative or postoperative blood transfusion |
| Within 72 hours of surgery start time |
| Number of Participants With Reported Device-related Adverse Events | Number of participants with reported device-related adverse events | Within 30-day post-operative period |
| Number of Participants With Product Malfunction | Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended. | Within surgery |
| 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 |
|
|
|
| Primary | Intraoperative Laparoscopic Staple Line Bleeding Score | Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Within surgery, images captured 10 seconds after the last stapler firing |
|
|
|
| Secondary | Number of Participants With Postoperative Leakage Requiring Intervention | Number of participants with postoperative leakage requiring intervention | Posted | Count of Participants | Participants | Within 30-day post-operative period |
|
|
|
| Secondary | Number of Participants With Intraoperative or Postoperative Blood Transfusion | Number of participants with intraoperative or postoperative blood transfusion | Posted | Count of Participants | Participants | Within 72 hours of surgery start time |
|
|
|
| Secondary | Number of Participants With Reported Device-related Adverse Events | Number of participants with reported device-related adverse events | Posted | Count of Participants | Participants | Within 30-day post-operative period |
|
|
|
| Secondary | Number of Participants With Product Malfunction | Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended. | Posted | Count of Participants | Participants | Within surgery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Endo GIA Reloads With Tri-Staple Technology | Stapling performed with Endo GIA Reloads with Tri-Staple Technology Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |