Evaluation of the Surfacer System Approach to Central Venous Access

NCT03209050 | Completed Results DMC FDA Device

• 1 other identifier: BVT.Surfacer.17-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Safe Insertion and Patency of Central Venous Access Catheter

  Safety reported as 86.7% (26/30) % of subjects with no procedural complications at discharge through 7 days follow up.

  7 days

Secondary Outcomes (1)

• Number of Participants Who Experienced Safe Use of the System to Insert Femoral Vein to Sub-clavicular Exit as Assessed by Central Venous Access Placement in 30 Patients Attempted

  7 days

Study Arms (1)

Central Venous Access Placement

OTHER

Central venous access placement

Device: Central Venous Access Placement

Interventions

Central Venous Access Placement DEVICE

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

Central Venous Access Placement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referred for placement of central venous access catheter
• have limited or diminishing upper body venous access
• have pathology impeding standard access methods
• willing to give written informed consent

You may not qualify if:

• occlusion of the right femoral vein
• occlusion of the iliac vein
• occlusion of the inferior vena cava
• contraindicated by physician
• acute thrombosis within any vessel planned to be crossed by the Surfacer \*tortuous anatomy which precludes a straight line from femoral vein to subclavian
• diagnosed with active pericarditis
• diagnosed with active endocarditis
• suspected pericardial effusion
• known or suspected aneurysm or ectasia of ascending aorta
• innominate artery or subclavian artery
• pregnant or of childbearing potential not taking adequate contraceptive measures or nursing during study

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (1)

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Clinical Research Organization and Trial Manager
• Organization: mmc medical international services

laura22@mmc-medical.com

9492805700

Study Officials

• Monica Tocchi, MD

  Meditrial Europe Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: patients requiring venous access

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: July 6, 2017
• Study Start: December 18, 2017
• Primary Completion: May 24, 2019
• Study Completion: June 1, 2019
• Last Updated: May 30, 2023
• Results First Posted: August 12, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)