NCT04656548

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

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

November 13, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

December 1, 2020

Last Update Submit

May 25, 2021

Conditions

Peripheral ICCPICC

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Comparison of failure rates

    August 2020 through October 2020

Study Arms (2)

HydroPICC

Cohort who received the HydroPICC

Device: HydroPICC

Standard of Care

Cohort who received something different than HydroPICC

Interventions

HydroPICCDEVICE

PICC lines

Also known as: Standard of Care
HydroPICC

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joseph Bunch

Romeoville, Illinois, 60446, United States

Location

Study Officials

  • Joseph Bunch

    ProVasc

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 7, 2020

Study Start

November 13, 2020

Primary Completion

April 23, 2021

Study Completion

April 23, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)