Midline Failures: A Comparison Between a Hydrophilic Biom... | NCT04911842

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

NCT04911842

Sponsor

Access Vascular Inc

Status

Completed

Last Update Posted

Feb 2, 2023Actual

Enrollment

205Actual

Phase

Not provided

Conditions

Midline Catheter

Interventions

HydroMID
TPU

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2021Actual

Primary Completion Date

Dec 2, 2021Actual

Completion Date

Jan 18, 2022Actual

First Submitted Date

May 25, 2021

First Submission Date that Met QC Criteria

May 28, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2023

Last Update Posted Date

Feb 2, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TPU		Thermoplastic polyurethane	Device: TPU
HBM		Hydrophilic BioMaterial	Device: HydroMID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HydroMID	Device	Hydrophilic biomaterial	HBM
TPU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who needed a 4 Fr single lumen midline

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joseph Bunch		Romeoville	Illinois	60446	United States