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The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.
A prospective study was conducted with 80 consecutive thoracic cases. Stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEON Endostapler | Stapling performed with AEON Endostapler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEON Endostapler | Device | Surgery with AEON Endostapler |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, up to 8 hours |
| Number of Participants With Intraoperative Staple Line Bleeding | Number of participants with intraoperative staple line bleeding | Within surgery, up to 8 hours |
| Number of Participants With Reported Device-related Adverse Events | Number of participants with reported device-related adverse events | Within 30-day post-operative period |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Hospital length of stay (days) | Following hospital admission, up to discharge |
| Chest Tube Removal | Time before chest tube removal (days) |
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Inclusion Criteria:
Exclusion Criteria:
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80 subjects meeting inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital St. Gallen | Sankt Gallen | 9001 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | AEON Endostapler | Stapling performed with AEON Endostapler AEON Endostapler: Surgery with AEON Endostapler |
| 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 |
| 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 | 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, up to 8 hours |
|
|
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 | |
|---|---|---|---|---|
| Dr. André E. Dutly | Kantonsspital St. Gallen | 071 494 9944 | andre.dutly@kssg.ch |
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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 | Nov 30, 2022 | Nov 30, 2022 | Prot_SAP_001.pdf |
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| Following surgery, up to chest tube removal |
| 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 |
|
|
| Primary | Number of Participants With Intraoperative Staple Line Bleeding | Number of participants with intraoperative staple line bleeding | Posted | Count of Participants | Participants | Within surgery, up to 8 hours |
|
|
|
| Primary | 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 | Hospital Length of Stay | Hospital length of stay (days) | Posted | Mean | Standard Deviation | days | Following hospital admission, up to discharge |
|
|
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| Secondary | Chest Tube Removal | Time before chest tube removal (days) | Posted | Mean | Standard Deviation | days | Following surgery, up to chest tube removal |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
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