An interventional study of ETHICON™ 4000 Stapler System and Standard of Care Stapler and Reloads in Surgical Procedures, Operative, sponsored by Ethicon Endo-Surgery. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Ethicon Endo-Surgery (part of Johnson & Johnson) · Not applicable, Interventional, and Other
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.
1,383 studies on the registry are indexed under Hemorrhage; 244 are open to participants now.
This study's planned enrollment of 300 is above the median of 102 across 926 interventional studies indexed under Hemorrhage.
Browse Hemorrhage studies →Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants for a gastric or thoracic surgery randomized to the standard of care arm will undergo the surgical procedure with a standard of care stapler and reloads, as per instructions for use (IFU).
Device: Standard of Care Stapler and Reloads
Eligible participants for a gastric or thoracic surgery randomized to the ETHICON 4000 arm will undergo the surgical procedure with the ETHICON 4000 Stapler System, as per IFU.
Device: ETHICON™ 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.
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.
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.
Time frame: Intraoperative
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.
Time frame: Intraoperative
Length of Hospital Stay
Number of days from the date of hospital admission to discharge from the hospital will be reported.
Time frame: Up to 30 Days Post Procedure
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.
Time frame: Up to 30 Days Post Procedure
Thoracic: Duration of Tube Placement
Duration of chest tube placement and removal will be reported.
Time frame: Up to 30 Days Post Procedure
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.
Time frame: Up to 30 Days Post Procedure
Thoracic: Percentage of Participants with Prolonged Air Leak (PAL)
PAL is defined as an air leak that persists more than (\>) 5 days after the study procedure.
Time frame: Up to 30 Days Post Procedure
No study locations are listed for this record.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson MedTech is available at 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
Data sharing details ↗ · www.jnj.com
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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