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

NCT07744568 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-08-04

No results posted yet for this study

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

Interventions

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.

DEVICE

Standard 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 & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Gianluca Casali, MD · Ethicon Endo-Surgery

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-16
Primary Completion
2027-12-01
Completion
2028-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744568 on ClinicalTrials.gov