CompletedNot Applicable

Surfacer System to Facilitate Access in Venous Occlusions

Austria, Germany, Italy30 participantsStarted 2017-02-07

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: patients referred for placement of a central venous catheter * 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)

What they're measuring

Absence of all acute safety and device related serious adverse event recorded on case report forms

Timeframe: Procedure through discharge at 24 hours post procedure. Data will be presented through study completion, 1 year.

Trial details

NCT IDNCT02875899

SponsorMerit Medical Systems, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-09-20

View on ClinicalTrials.gov More Chronic Venous Thrombosis trials