A Comparative, Retrospective Chart Review of Intended Dwe... | NCT04656548

Studies
A Comparative, Retrospective Chart Review of Intended Dwell Time of a PICC Line

NCT04656548

Sponsor

Access Vascular Inc

Status

Completed

Last Update Posted

May 26, 2021Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Peripheral ICC
PICC

Interventions

HydroPICC

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

May 2021

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

Nov 13, 2020Actual

Primary Completion Date

Apr 23, 2021Actual

Completion Date

Apr 23, 2021Actual

First Submitted Date

Dec 1, 2020

First Submission Date that Met QC Criteria

Dec 1, 2020

First Posted Date

Dec 7, 2020Actual

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

May 25, 2021

Last Update Posted Date

May 26, 2021Actual

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

This is a retrospective, matched pair comparative post market review of 4Fr Single Lumen PICC lines. The subjects will be matched by the timeframe of when the HydroPICCs were inserted.

Detailed Description

Subjects would have received a 4 Fr Single Lumen PICC line between Aug 2020 and Oct 2020.

The two groups will be HydroPICCs and the standard of care for the facility.

A comparison of multiple endpoints will be evaluated between the two groups.

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

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HydroPICC		Cohort who received the HydroPICC	Device: HydroPICC
Standard of Care		Cohort who received something different than HydroPICC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HydroPICC	Device	PICC lines	HydroPICC	Standard of Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intended dwell time based on a comparison of the actual dwell time to the intended time	Comparison of actual vs intended dwell times of each arm	August 2020 through October 2020

Secondary Outcomes

Measure	Description	Time Frame
Comparison of failure rates	Compare the failure rates between the two arms	August 2020 through October 2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have been inserted with the HydroPICC during a specific time range.
During the same time period, any competitor 4 Fr single lumen placed.

Exclusion Criteria:

None

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

Any patients at the study site that received a 4 Fr single lumen PICC line from Aug 2020 through Oct 2020.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph Bunch	ProVasc	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided