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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04656548
Other study ID # CLIN 20-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 13, 2020
Est. completion date April 23, 2021

Study information

Verified date May 2021
Source Access Vascular Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date April 23, 2021
Est. primary completion date April 23, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
HydroPICC
PICC lines

Locations

Country Name City State
United States Joseph Bunch Romeoville Illinois

Sponsors (1)

Lead Sponsor Collaborator
Access Vascular Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Comparison of failure rates Compare the failure rates between the two arms August 2020 through October 2020
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05702515 - Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study
Terminated NCT04920929 - PICC Asymptomatic Thrombosis Study: A Pilot Study N/A