Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane
Sponsor
Access Vascular Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04911842
Collaborator
(none)
200
1
4.4
45.4
Study Details
Study Description
Brief Summary
Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
200 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Midline Failures: A Comparative, Retrospective Chart Review
Actual Study Start Date
:
May 20, 2021
Anticipated Primary Completion Date
:
Oct 1, 2021
Anticipated Study Completion Date
:
Oct 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| TPU Thermoplastic polyurethane |
Device: TPU
Thermoplastic polyurethane
|
| HBM Hydrophilic BioMaterial |
Device: HydroMID
Hydrophilic biomaterial
|
Outcome Measures
Primary Outcome Measures
- The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials. [retrospective review- March 2021 through May 2021]
Secondary Outcome Measures
- To compare the proportion of times the midline was used to successfully complete prescribed length. [retrospective review- March 2021 through May 2021]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects who have been inserted with the HydroMID by the vascular access group
-
Subjects who have been inserted with a competitor 4 Fr single lumen by the vascular access team
Exclusion Criteria:
- Any off-label use (PICC lines cut to be midlines for any manufacturer)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Joseph Bunch | Romeoville | Illinois | United States | 60446 |
Sponsors and Collaborators
- Access Vascular Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Access Vascular Inc
ClinicalTrials.gov Identifier:
NCT04911842
Other Study ID Numbers:
- CLIN 21-001
First Posted:
Jun 3, 2021
Last Update Posted:
Sep 14, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No