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NCT Number: NCT07744568

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

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.

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Key information

Conditions

Surgical Procedures, Operative Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Health Sciences University, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line

    Time frame: 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.

  2. Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line

    Time frame: 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 outcomes

  1. Length of Hospital Stay

    Time frame: Up to 30 Days Post Procedure

    Number of days from the date of hospital admission to discharge from the hospital will be reported.

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

    Time frame: Up to 30 Days Post Procedure

    Percentage of participants experiencing gastric leak occurring up to 30 days post procedure will be reported.

  3. Thoracic: Duration of Tube Placement

    Time frame: Up to 30 Days Post Procedure

    Duration of chest tube placement and removal will be reported.

  4. Thoracic: Postoperative Air Leak Duration

    Time frame: 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.

  5. Percentage of Participants with Prolonged Air Leak (PAL)

    Time frame: Up to 30 Days Post Procedure

    PAL is defined as an air leak that persists more than (>) 5 days after the study procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Kari Loing

CONTACT

[email protected]

(513) 337-7000

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

A Post Market, Two-Arm, Multi-Center, Randomized Controlled Trial Comparing Clinical Outcomes Using the ETHICON™ 4000 Stapler System Versus Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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