Surfacer System to Facilitate Access in Venous Occlusions

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

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-07

Study Completion Date

2018-10-04

Brief Summary

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Prospective, single-arm, multicentre, international Registry of the Surfacer System for the treatment of patients with limited or diminishing upper body venous access or pathology impeding standard access methods.The purpose of this post-market Registry is to assess the standard of care and clinical outcomes of the Surfacer System used in clinical routine according to the approved commercial indications.

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Detailed Description

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This is a prospective, single-arm, multicenter registry of the Surfacer System for patients with limited or diminishing upper body venous access or pathology impeding standard access methods. The need for long term access and lack of availability of veins has led to the development of the Surfacer System, which facilitates reliable and repeatable placement of central venous catheters and restores central venous access. Based on European legislation, this Registry is considered to be an observational study. No additional diagnostic or monitoring procedures as a result of the inclusion are applied to the patients. Available data will be collected in a protected database. Up to 30 patients will be enrolled in 5 sites in Europe. Patients requiring central venous access will be enrolled who meet inclusion and exclusion criteria and for whom the device is indicated.

Conditions

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Chronic Venous Thrombosis Venous Thrombosis Upper Extremity Venous Thrombosis Upper Extremity Superficial Veins

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients with limited or diminishing upper body venous access
* pathology impeding standard access methods
* signed informed consent

Exclusion Criteria

* vulnerable subjects or incapable of giving consent
* contraindications to central venous access based on treating physicians opinion or standard of care
* occlusion of the right femoral vein
* occlusion of the iliac vein
* occlusion of the inferior vena
* acute thrombosis within a vessel (IVC, brachiocephalic and subclavian)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No