Vurdering af GORE® SYNECOR biomateriale i fokuserede patientpopulationer og langsigtet anvendelse (SYN 20-01)
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application.
Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Birmingham, Det Forenede Kongerige, B15 2GW
- University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
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Walsall, Det Forenede Kongerige, WS2 9PS
- Walsall Manor Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Emory Saint Joseph's Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
- Tufts Medical Center
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49506
- Corewell Health
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87109
- Lovelace Women's Hospital
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New York
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Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University Hospital
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North Carolina
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Wilmington, North Carolina, Forenede Stater, 28401
- Novant Health New Hanover Regional Medical Center
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Prisma Health Greenville Memorial Hospital
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Virginia
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Mechanicsville, Virginia, Forenede Stater, 23116
- Bon Secours Memorial Regional Medical Center
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Baggiovara, Italien, 41126
- Ospedale Civile di Baggiovara
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Naples, Italien, 80131
- Vincenzo Monaldi Hospital
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Roma, Italien, 00189
- Sapienza Università di Roma
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Seville, Spanien, 41009
- University Hospital Virgen Macarena - Department of General And Digestive Surgery
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Seville, Spanien, 41013
- Hospital Quirón Salud-Sagrado Corazón
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The SYN 20-01 study population will consist of patients who present with ventral/incisional hernia disease requiring treatment per the evaluating physician. Eligible study subjects need to be amenable to treatment with a permanent synthetic mesh as suggested by the inclusion and exclusion criteria for each study cohort.
Beskrivelse
Key Inclusion Criteria - IP Cohort:
- De-Novo ventral/incisional hernia amenable to repair with GORE® SYNECOR IP Biomaterial
- Clean wound (CDC Wound Class I)
- mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)
Key Exclusion Criteria - IP Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
Key Inclusion Criteria - PRE Cohort:
- De-novo ventral/incisional hernia, with subject anatomy and surgical plan amenable to open surgical repair or minimally invasive surgery with the GORE® SYNECOR PRE Biomaterial placed in a sublay fashion within the preperitoneal space
- Clean wound (CDC Wound Class I)
- mVHWG Grade 1 or 2 (modified Ventral Hernia Working Group)
Key Exclusion Criteria - PRE Cohort:
- Wound is either clean-contaminated, contaminated or dirty-infected
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
SYNECOR IP Device
Hernia mesh repair with GORE® SYNECOR Intraperitoneal Biomaterial |
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery |
|
SYNECOR PRE Device
Hernia mesh repair with GORE® SYNECOR Preperitoneal Biomaterial |
Hernia repair with GORE® SYNECOR Biomaterial; technical approach laparoscopic, robotic or open surgical / minimally invasive surgery |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hernia Recurrence
Tidsramme: 24 Months
|
Hernia Recurrence Treated Location |
24 Months
|
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Hernia Recurrence
Tidsramme: 60 Months
|
Hernia Recurrence Treated Location |
60 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital Re-Admission
Tidsramme: 60 Months
|
Device or procedural-related |
60 Months
|
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Thirty-Day Mortality
Tidsramme: 30 Day
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Mortality of all causes |
30 Day
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|
SSO within 24 months post-procedure
Tidsramme: 24 Months
|
Surgical Site Occurrence (SSO) |
24 Months
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SSI (Surgical Site Infection)
Tidsramme: 60 Months
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Surgical Site Infection (SSI) |
60 Months
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Freedom from mesh-involved events
Tidsramme: 60 Months
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Freedom from mesh-involved events |
60 Months
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Major Seroma (clinically confirmed)
Tidsramme: 60 Months
|
Major Seroma as clinically assessed (physiological parameters) and defined as seroma requiring treatment in the presence of infection, recurrence, mesh rejection or the need to be punctured/aspirated will be described without specific hypothesis or formal goal. Number of subjects with reported major seroma will be described as clinically confirmed by the investigator. |
60 Months
|
|
Change in Quality of Life (QoL) - SF 36 Questionnaire
Tidsramme: 60 Months
|
SF 36 Questionnaire (36-Item Short Form Survey Instrument; possible score ranges from 0 to 100 points. 0 points represent the greatest possible limitation of health, while 100 points represent the absence of health restrictions) |
60 Months
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Change in Quality of Life (QoL) - Carolinas Comfort Scale (CCS)
Tidsramme: 60 Months
|
Carolinas Comfort Scale (CCS); CCS was designed that a lower score indicates a favorable health status; the total score is based on a scale of 0 - 115) |
60 Months
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Ventral Hernia Recurrence Inventory sensitivity / specificity within 60 Month Follow-Up
Tidsramme: 60 Months
|
VHRI Survey (Ventral Hernia Recurrence Inventory) |
60 Months
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Adverse Events by Clavien Dindo Classification
Tidsramme: 60 Months
|
Adverse Events by Clavien Dindo Classification |
60 Months
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Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Tidsramme: 24 Months
|
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention |
24 Months
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Surgical Site Occurrences (SSOPI) requiring Procedural Intervention
Tidsramme: 60 Months
|
Surgical Site Occurrences (SSOPI) requiring Procedural Intervention |
60 Months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SYN 20-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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