US Post-Market Surveillance Study of the Surfacer System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-08

Study Completion Date

2026-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No