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This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECHELON FLEXâ„¢ Powered Plus Stapler | Device | ECHELON FLEXâ„¢ Powered Plus Stapler using ENDOPATH ECHELONâ„¢ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEXâ„¢ GST System. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical interventions (type, quantity, frequency, rationale) required during LSG | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | Up to one day | |
| Length of stay | Up to 4 weeks | |
| Estimated blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals scheduled for laparoscopic sleeve gastrectomy
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| Name | Affiliation | Role |
|---|---|---|
| Adolfo Fernandez, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgical Specialists of Louisiana | Metairie | Louisiana | 70001 | United States | ||
| Carolinas Weight Management |
via publication
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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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| up to one day |
| Charlotte |
| North Carolina |
| 28204 |
| United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |