The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach surgeries and by evaluating the side effects occurring within 30 days of surgery.
Prior to study enrollment, the participant and treating surgeon must have determined to proceed with one of the following surgical procedures as part of routine clinical care: a. A gastric procedure (sleeve gastrectomy) involving stapling of the stomach; or b. A thoracic procedure (lung resection limited to lobectomy, segmentectomy, or wedge resection) involving stapling of the lung
Willingness to give consent and comply with all study-related evaluations and visit schedule
At least 18 years of age
Physical or psychological condition which would impair study participation
The planned procedure is a revision/ reoperation for the same indication or same anatomical location
Trauma participants
Any condition or clinically significant finding that, in the Investigator's judgement, may interfere with study participation, impact the assessment of endpoints, or compromise the patient's safety or welfare
Parallel
ETHICON™ 4000 Stapler System
DeviceThe Investigator will use the ETHICON™ 4000 Stapler System, as per instructions for use (IFU). This system is composed of two primary components: The ETHICON 4000 Stapler and the ETHICON 3D Reloads.
Standard of Care Stapler and Reloads
DeviceThe Investigator will choose a commercially available stapler and reload(s) per their professional preference produced by any manufacturer and aligned with the manufacturer's IFU. The only exception is that the Investigator may not use the ETHICON™ 4000 Stapler System.
Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line
Percentage of firings associated with each intraoperative grade of bleeding at the staple line (prior to prophylactic or intervention to the staple line) will be reported. The percentage of staple firings for each bleeding grade and for bleeding scores of 4 or below, 3 or below, 2 or below, 1 or below, and 0 will be estimated.
Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line
Percentage of firings associated with intraoperative air leak at the staple line (prior to prophylactic or intervention to the staple line) will be reported.
Length of Hospital Stay
Number of days from the date of hospital admission to discharge from the hospital will be reported.
Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure
Percentage of participants experiencing gastric leak occurring up to 30 days post procedure will be reported.
Thoracic: Duration of Tube Placement
Duration of chest tube placement and removal will be reported.
Thoracic: Postoperative Air Leak Duration
Postoperative air leak duration upon submersion test (prior to prophylactic or intervention to the staple line) using a binary determination (air leak, yes/no) will be reported.
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