US Post-Market Surveillance Study of the Surfacer System

Venous Disease Clinical Trial

Official title:

US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050799
• Other study ID #: CVO-P4-23-01
• Status: Recruiting
• Start date: February 8, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: February 2024
• Source: Merit Medical Systems, Inc.
• Contact: Casey Holland, MS
• Phone: 6178420251
• Email: casey.holland[@]merit.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.

2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods

3. Subjects are willing and able to give written informed consent

Exclusion Criteria:

1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava

2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)

3. Occlusion within the arterial system

4. Occlusion within the coronary or cerebral vasculature

Related Conditions & MeSH terms

• Venous Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor Scott & White Heart and Vascular Hospital	Dallas	Texas
United States	Flow Vascular Institute	Pasadena	Texas
United States	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Pima Heart and Vascular	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Venous Access operational	safe insertion of the device to facilitate central venous access	24 hours
Primary	Incidence of adverse events through 24 hours	no procedural adverse events or peri procedural adverse events	24 hours