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Evaluation of the Surfacer System Approach to Central Venous Access

NCT03209050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-30

Study results available
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Summary

Pre-market Investigational device exemption study evaluating the safety and efficacy of the Surfacer System to facilitate stable upper body central venous access suitable for any conventional catheter.

Conditions

  • Venous Occlusion

Interventions

DEVICE

Central Venous Access Placement

Device inserted into the femoral vein to insert a central venous access catheter

Sponsors & Collaborators

  • Meditrial Europe Ltd.

    collaborator INDUSTRY

  • Merit Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Monica Tocchi, MD · Meditrial Europe Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2019-05-24
Completion
2019-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209050 on ClinicalTrials.gov