Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane

January 31, 2023 updated by: Access Vascular Inc

Midline Failures: A Comparative, Retrospective Chart Review

Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Romeoville, Illinois, United States, 60446
        • Joseph Bunch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who needed a 4 Fr single lumen midline

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TPU
Thermoplastic polyurethane
Device: TPU
Thermoplastic polyurethane
HBM
Hydrophilic BioMaterial
Device: HydroMID
Hydrophilic biomaterial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials.
Time Frame: retrospective review- March 2021 through May 2021
retrospective review- March 2021 through May 2021

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare the proportion of times the midline was used to successfully complete prescribed length.
Time Frame: retrospective review- March 2021 through May 2021
retrospective review- March 2021 through May 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Access Vascular Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

January 18, 2022

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CLIN 21-001

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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