A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
1. september 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kari Loing
- Telefonnummer: (513) 337-7000
- E-post: RA-ESC202408@its.jnj.com
Studiesteder
-
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California
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Los Angeles, California, Forente stater, 90048
- Cedars Sinai Health Sciences University
-
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Indiana
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Indianapolis, Indiana, Forente stater, 46143
- Franciscan Saint Francis Hospital
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Henry Ford Hospital
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Missouri
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Columbia, Missouri, Forente stater, 65212
- University of Missouri
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St Louis, Missouri, Forente stater, 63110
- Washington University School of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny General Hospital of Research
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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).
|
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.
|
|
Eksperimentell: 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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Gastrointestinal- Percentage of Firings Associated with Each Intraoperative Grade of Bleeding at the Staple Line
Tidsramme: Intraoperative
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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.
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Intraoperative
|
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Thoracic- Percentage of Firings Associated with Intraoperative Air Leak at the Staple Line
Tidsramme: Intraoperative
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Percentage of firings associated with intraoperative air leak at the staple line (prior to prophylactic or intervention to the staple line) will be reported.
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Intraoperative
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Length of Hospital Stay
Tidsramme: Up to 30 Days Post Procedure
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Number of days from the date of hospital admission to discharge from the hospital will be reported.
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Up to 30 Days Post Procedure
|
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Gastrointestinal: Percentage of Participants Experiencing Gastric Leak Up to 30 Days Post-Procedure
Tidsramme: Up to 30 Days Post Procedure
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Percentage of participants experiencing gastric leak occurring up to 30 days post procedure will be reported.
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Up to 30 Days Post Procedure
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Thoracic: Duration of Tube Placement
Tidsramme: Up to 30 Days Post Procedure
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Duration of chest tube placement and removal will be reported.
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Up to 30 Days Post Procedure
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Thoracic: Postoperative Air Leak Duration
Tidsramme: Up to 30 Days Post Procedure
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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.
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Up to 30 Days Post Procedure
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Thoracic: Percentage of Participants with Prolonged Air Leak (PAL)
Tidsramme: Up to 30 Days Post Procedure
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PAL is defined as an air leak that persists more than (>) 5 days after the study procedure.
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Up to 30 Days Post Procedure
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Gianluca Casali, MD, Ethicon Endo-Surgery
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
16. september 2026
Primær fullføring (Antatt)
1. desember 2027
Studiet fullført (Antatt)
28. februar 2028
Datoer for studieregistrering
Først innsendt
30. juli 2026
Først innsendt som oppfylte QC-kriteriene
30. juli 2026
Først lagt ut (Faktiske)
4. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ESC202408
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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