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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ethicon Endo-Surgery
Study ID
NCT07744568
Status
Not Yet Recruiting

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Conditions

  • Surgical Procedures, Operative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Sep 16, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Standard of Care Stapler System
    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).
  • Experimental: ETHICON 4000 Stapler System
    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.

Primary Outcome Measure

Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line [ Time Frame: Intraoperative ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Cedars Sinai Health Sciences UniversityLos AngelesCalifornia90048-
Franciscan Saint Francis HospitalIndianapolisIndiana46143-
Henry Ford HospitalDetroitMichigan48202-
University of MissouriColumbiaMissouri65212-
Washington University School Of MedicineSt LouisMissouri63110-
Allegheny General Hospital of ResearchPittsburghPennsylvania15212-

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Health Sciences University· Los Angeles, CAFranciscan Saint Francis Hospital· Indianapolis, INHenry Ford Hospital· Detroit, MIUniversity of Missouri· Columbia, MOWashington University School Of Medicine· St Louis, MOAllegheny General Hospital of Research· Pittsburgh, PA

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