NCT04911842

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2022

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 25, 2021

Last Update Submit

January 31, 2023

Conditions

Midline Catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To compare the proportion of times the midline was used to successfully complete prescribed length.

    retrospective review- March 2021 through May 2021

Study Arms (2)

TPU

Thermoplastic polyurethane

Device: TPU

HBM

Hydrophilic BioMaterial

Device: HydroMID

Interventions

HydroMIDDEVICE

Hydrophilic biomaterial

HBM
TPUDEVICE

Thermoplastic polyurethane

TPU

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who needed a 4 Fr single lumen midline

You may qualify if:

  • 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

You may not qualify if:

  • Any off-label use (PICC lines cut to be midlines for any manufacturer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Bunch

Romeoville, Illinois, 60446, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 3, 2021

Study Start

May 20, 2021

Primary Completion

December 2, 2021

Study Completion

January 18, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations

US(1)