A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures

NCT07744568 | Not Yet Recruiting FDA Device

• 1 other identifier: ESC202408
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

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.

Conditions

Surgical Procedures, Operative

Keywords

surgical stapler, endocutter, reload, staple line, sleeve gastrectomy, lung resection, prolonged air leak, bleeding, intraoperative, ETHICON 4000

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Intraoperative

Secondary Outcomes (5)

• Length of Hospital Stay

  Up to 30 Days Post Procedure

• Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure

  Up to 30 Days Post Procedure

• Thoracic: Duration of Tube Placement

  Up to 30 Days Post Procedure

• Thoracic: Postoperative Air Leak Duration

  Up to 30 Days Post Procedure

• Percentage of Participants with Prolonged Air Leak (PAL)

  Up to 30 Days Post Procedure

Study Arms (2)

Standard of Care Stapler System

ACTIVE COMPARATOR

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

ETHICON 4000 Stapler System

EXPERIMENTAL

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

Interventions

ETHICON™ 4000 Stapler System DEVICE

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.

ETHICON 4000 Stapler System

Standard of Care Stapler and Reloads DEVICE

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.

Standard of Care Stapler System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for a gastric procedure (sleeve gastrectomy) where a surgical stapler is intended to be used on the stomach; or candidate for a thoracic procedure (lung resection; only lobectomy, segmentectomy or wedge) where a surgical stapler is intended to be used on the lung
• Willingness to give consent and comply with all study-related evaluations and visit schedule
• At least 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (6)

Cedars Sinai Health Sciences University

Los Angeles, California, 90048, United States

Location

Franciscan Saint Francis Hospital

Indianapolis, Indiana, 46143, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Allegheny General Hospital of Research

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (1)

• Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.surg.2016.09.022. Epub 2016 Nov 10.

  PMID: 27839931 BACKGROUND

Related Links

• Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents.

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Casali, MD

  Ethicon Endo-Surgery

  STUDY DIRECTOR

Central Study Contacts

Kari Loing

CONTACT

(513) 337-7000; RA-ESC202408@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (6)