US Post-Market Surveillance Study af Surfacer System
US Post-Market Surveillance Study af Surfacer* Inside-Out* Access Catheter System (Surfacer System)
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.
Studieoversigt
Detaljeret beskrivelse
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Hannah Susmeyer
- Telefonnummer: 978-758-6166
- E-mail: Hannah.Susmeyer@merit.com
Undersøgelse Kontakt Backup
- Navn: Vicky Brunk, RN
- Telefonnummer: 717-873-3309
- E-mail: Vicky.Brunk@merit.com
Studiesteder
-
-
Arizona
-
Tucson, Arizona, Forenede Stater, 85704
- Afsluttet
- Pima Heart and Vascular
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20010
- Rekruttering
- Medstar Washington Hospital Center
-
-
Florida
-
Sarasota, Florida, Forenede Stater, 34239
- Rekruttering
- Sarasota Memorial Health Care System
-
-
Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Emory University Hospital
-
-
Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Rekruttering
- Ohio State University Hospital
-
-
Texas
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Dallas, Texas, Forenede Stater, 75226
- Rekruttering
- Baylor Scott & White Heart and Vascular Hospital
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- The University of Texas Health Science Center at Houston
-
Pasadena, Texas, Forenede Stater, 77504
- Afsluttet
- Flow Vascular Institute
-
-
Utah
-
Millcreek, Utah, Forenede Stater, 84124
- Rekruttering
- St. Mark's Hospital
-
-
Virginia
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Norfolk, Virginia, Forenede Stater, 23507
- Rekruttering
- Sentara Norfolk General Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods and who meet requirements in the labeling of the IFU.
Beskrivelse
Inclusion Criteria:
- Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
- Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
- Subjects are willing and able to give written informed consent
Exclusion Criteria:
- Occlusion of the right femoral vein, right iliac vein or inferior vena cava
- Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
- Occlusion within the arterial system
- Occlusion within the coronary or cerebral vasculature
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Central Venous Access operational
Tidsramme: 24 hours
|
safe insertion of the device to facilitate central venous access |
24 hours
|
|
Incidence of adverse events through 24 hours
Tidsramme: 24 hours
|
no procedural adverse events or peri procedural adverse events |
24 hours
|
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
Andre undersøgelses-id-numre
- CVO-P4-23-01
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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