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US Post-Market Surveillance Study of the Surfacer System

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ClinicalTrials.gov Identifier: NCT05050799
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Bluegrass Vascular Technologies

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Venous Disease Device: Central Venous Access

Detailed Description:
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 10-12 sites in the United States, with no site enrolling more than 3 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)
Actual Study Start Date : February 8, 2022
Estimated Primary Completion Date : August 10, 2023
Estimated Study Completion Date : October 1, 2023
Groups and Cohorts
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Intervention Details:
  • Device: Central Venous Access
    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.

Outcome Measures
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Primary Outcome Measures :
  1. Central Venous Access operational [ Time Frame: 24 hours ]
    insertion of the device to facilitate central venous access

  2. Incidence of adverse events through 24 hours [ Time Frame: 24 hours ]
    no procedural adverse events or peri procedural adverse events


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

Subjects have require central venous access and require placement of a central venous catheter.

Has venous occlusive disease and conventional access methods are limited. Subject must be willing and able to give a written consent.

Exclusion Criteria:

Occlusion of the Right femoral vein Occlusion of the Right iliac vein Occlusion of the Inferior Vena Cava Any thrombosis in a vessel that will be crossed by the Surfacer device

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050799


Contacts
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Contact: Gabi Niederauer, Ph.D 2103255194 gniederauer@bluegrassvascular.com
Contact: Donna L Merithew, BS 19492940584 donna@mmc-medical.com

Locations
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United States, Texas
Flow Vascular Institute Recruiting
Pasadena, Texas, United States, 77504
Contact: Chris Durham, MD    832-947-4783    durham@flowvascular.com   
Contact: Danel Monroe    8329474783      
Sponsors and Collaborators
Bluegrass Vascular Technologies
Investigators
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Study Director: Laura Minarsch, BS Clinical Affairs Director
More Information
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Responsible Party: Bluegrass Vascular Technologies
ClinicalTrials.gov Identifier: NCT05050799    
Other Study ID Numbers: PMS2020
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No