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

1. september 2026 opdateret af: Ethicon Endo-Surgery

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90048
        • Cedars Sinai Health Sciences University
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46143
        • Franciscan Saint Francis Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65212
        • University of Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny General Hospital of Research

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion criteria:

  • Prior to study enrollment, the participant and treating surgeon must have determined to proceed with one of the following surgical procedures as part of routine clinical care: a. A gastric procedure (sleeve gastrectomy) involving stapling of the stomach; or b. A thoracic procedure (lung resection limited to lobectomy, segmentectomy, or wedge resection) involving stapling of 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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).
Enhed: 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.
Eksperimentel: 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.
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line
Tidsramme: 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.
Intraoperative
Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line
Tidsramme: 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.
Intraoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of Hospital Stay
Tidsramme: Up to 30 Days Post Procedure
Number of days from the date of hospital admission to discharge from the hospital will be reported.
Up to 30 Days Post Procedure
Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure
Tidsramme: Up to 30 Days Post Procedure
Percentage of participants experiencing gastric leak occurring up to 30 days post procedure will be reported.
Up to 30 Days Post Procedure
Thoracic: Duration of Tube Placement
Tidsramme: Up to 30 Days Post Procedure
Duration of chest tube placement and removal will be reported.
Up to 30 Days Post Procedure
Thoracic: Postoperative Air Leak Duration
Tidsramme: 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.
Up to 30 Days Post Procedure
Thoracic: Percentage of Participants with Prolonged Air Leak (PAL)
Tidsramme: Up to 30 Days Post Procedure
PAL is defined as an air leak that persists more than (>) 5 days after the study procedure.
Up to 30 Days Post Procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ethicon Endo-Surgery

Efterforskere

  • Studieleder: Gianluca Casali, MD, Ethicon Endo-Surgery

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

16. september 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

28. februar 2028

Datoer for studieregistrering

Først indsendt

30. juli 2026

Først indsendt, der opfyldte QC-kriterier

30. juli 2026

Først opslået (Faktiske)

4. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ESC202408

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data sharing policy of Johnson & Johnson MedTech is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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