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| ID | Type | Description | Link |
|---|---|---|---|
| ESC202103 | Other Identifier | Ethicon, Inc. |
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The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (Video-Assisted Thoracoscopic [ATS] or open approach).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECHELON 3000 Stapler | This prospective study will include the participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure and collect clinical data in a post-market setting. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON 3000 Stapler and reloads instructions for use (IFU). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECHELON 3000 Stapler | Device | There is no intervention, beyond necessary clinical care, in this study. Echelon 3000 Stapler is used for transection and resection in LSG or lung surgical procedure per its IFU. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Select Device-related Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence, regardless of its relationship to study device or study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of pre-existing condition, which occurs throughout the duration of the clinical study. SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect. The device-related SAEs that will be captured are infection or symptoms of infection, bleeding, gastric leak (laparoscopic sleeve gastrectomy [LSG] only), and postoperative air leak (lung resection only). | 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with All Device-related, Procedure-related Adverse Events (AEs) | An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. | 30 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who plan to have a laparoscopic sleeve gastrectomy (LSG) or lung resection surgical procedure will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Ethicon Endo-Surgery Clinical Trial | Ethicon Endo-Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| George Washington University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27162678 | Background | Qiu B, Yan W, Chen K, Fu X, Hu J, Gao S, Knippenberg S, Schwiers M, Kassis E, Yang T. A multi-center evaluation of a powered surgical stapler in video-assisted thoracoscopic lung resection procedures in China. J Thorac Dis. 2016 May;8(5):1007-13. doi: 10.21037/jtd.2016.03.88. | |
| 27991838 | Background | Fegelman E, Knippenberg S, Schwiers M, Stefanidis D, Gersin KS, Scott JD, Fernandez AZ. Evaluation of a Powered Stapler System with Gripping Surface Technology on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):489-494. doi: 10.1089/lap.2016.0513. Epub 2016 Dec 19. |
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The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| Number of Participants with All Device-related, Procedure-related SAEs | An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study. A SAE is defined as an AE that results in any of the following: death; a life-threatening illness or injury; a permanent impairment of a body structure or a body function; hospitalization or prolongation of existing hospitalization; medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function; chronic disease; fetal distress, fetal death, or a congenital physical or mental impairment or birth defect. | 30 days post-procedure |
| Washington D.C. |
| District of Columbia |
| 20037 |
| United States |
| Emory Cardiothoracic Surgery | Atlanta | Georgia | 30322 | United States |
| Henry Ford Health Center | Detroit | Michigan | 48202 | United States |
| Ascension Providence Hospital | Southfield | Michigan | 48075 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Bariatric Medical Institute of Texas | San Antonio | Texas | 78258 | United States |