Surgical Procedures, Operative
Conditions
Keywords
surgical stapler, endocutter, reload, staple line, sleeve gastrectomy, lung resection, prolonged air leak, bleeding, intraoperative, ETHICON 4000
Brief summary
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.
Interventions
DEVICEETHICON™ 4000 Stapler System
The 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.
DEVICEStandard of Care Stapler and Reloads
The 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.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Any medical condition that the Investigator deems could impact inflammatory or immune response * Enrollment in a concurrent interventional clinical study that could impact the study endpoints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line | Intraoperative | 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 | Intraoperative | Percentage of firings associated with intraoperative air leak at the staple line (prior to prophylactic or intervention to the staple line) will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | Up to 30 Days Post Procedure | 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 | 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 | Up to 30 Days Post Procedure | Duration of chest tube placement and removal will be reported. |
| Thoracic: Postoperative Air Leak Duration | Up to 30 Days Post Procedure | 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. |
| Thoracic: Percentage of Participants with Prolonged Air Leak (PAL) | Up to 30 Days Post Procedure | PAL is defined as an air leak that persists more than (\>) 5 days after the study procedure. |
Contacts
CONTACTKari Loing
STUDY_DIRECTORGianluca Casali, MD
Ethicon Endo-Surgery
Outcome results
None listed