US Post-Market Surveillance Study of the Surfacer System

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Merit Medical Systems, Inc.
Study ID
NCT05050799
Status
Recruiting

Conditions

  • Venous Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Central Venous Access — DEVICE
    The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

Study Details

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.

Key Dates

Start date
Feb 8, 2022
Status verified
May 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Central Venous Access operational [ Time Frame: 24 hours ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Pima Heart and VascularTucsonArizona85704-
Sarasota Memorial Health Care SystemSarasotaFlorida34239-
Emory University HospitalAtlantaGeorgia30322-
Ohio State University HospitalColumbusOhio43210-
Baylor Scott & White Heart and Vascular HospitalDallasTexas75226-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
Flow Vascular InstitutePasadenaTexas77504-
St. Mark's HospitalMillcreekUtah84124-
Sentara Norfolk General HospitalNorfolkVirginia23507-

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