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Not yet recruiting NCT07744568

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

No phase Interventional Surgical Procedures, Operative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ETHICON™ 4000 Stapler System, Standard of Care Stapler and Reloads.
Who it may be relevant to
Registry conditions: Surgical Procedures, Operative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

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.

Primary outcome measures

  • Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line [Time frame: Intraoperative]
  • Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line [Time frame: Intraoperative]
Secondary outcome measures (5)
  • Length of Hospital Stay [Time frame: Up to 30 Days Post Procedure]
  • Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure [Time frame: Up to 30 Days Post Procedure]
  • Thoracic: Duration of Tube Placement [Time frame: Up to 30 Days Post Procedure]
  • Thoracic: Postoperative Air Leak Duration [Time frame: Up to 30 Days Post Procedure]
  • Percentage of Participants with Prolonged Air Leak (PAL) [Time frame: Up to 30 Days Post Procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 6 centers
  • Cedars Sinai Health Sciences University — Los Angeles
  • Franciscan Saint Francis Hospital — Indianapolis
  • Henry Ford Hospital — Detroit
  • University of Missouri — Columbia
  • Washington University School Of Medicine — St Louis
  • Allegheny General Hospital of Research — Pittsburgh

Publications

  • 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

Identifiers

NCT: NCT07744568 · ESC202408

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗