US Post-Market Surveillance Study of the Surfacer System
1 other identifier
observational
30
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2022
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 21, 2021
CompletedStudy Start
First participant enrolled
February 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
August 5, 2025
July 1, 2025
4.9 years
September 10, 2021
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Central Venous Access operational
safe insertion of the device to facilitate central venous access
24 hours
Incidence of adverse events through 24 hours
no procedural adverse events or peri procedural adverse events
24 hours
Interventions
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.
Eligibility Criteria
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 requirements in the labeling of the IFU.
You may qualify if:
- Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc.
- Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods
- Subjects are willing and able to give written informed consent
You may not qualify if:
- Occlusion of the right femoral vein, right iliac vein or inferior vena cava
- Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian)
- Occlusion within the arterial system
- Occlusion within the coronary or cerebral vasculature
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pima Heart and Vascular
Tucson, Arizona, 85704, United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239, United States
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, 75226, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Flow Vascular Institute
Pasadena, Texas, 77504, United States
St. Mark's Hospital
Millcreek, Utah, 84124, United States
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2021
First Posted
September 21, 2021
Study Start
February 8, 2022
Primary Completion (Estimated)
December 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share