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Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT04846374
Collaborator
(none)
20
Enrollment
1
Location
30.2
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose: To describe a novel configuration of venous access for the performance of intermittent apheresis.

Participants: 20 participants at UNC who were referred for change from a vortex port to a powerflow port.

Procedures (methods): Placement of one of two configurations of the powerflow port and follow up visits between January 1, 2019 and December 31, 2023.

Condition or Disease Intervention/Treatment Phase
  • Device: PowerPort

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
PowerPort Subjects

This study will involve a chart review of patients at UNC who were referred for change from a vortex port to a powerflow port.

Device: PowerPort
The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations.

Outcome Measures

Primary Outcome Measures

  1. Change in Flow Rate [1 year following new port configuration placement]

    The study will compare mean change flow rate for pheresis sessions with the old system versus pheresis sessions with one of two new configurations by averaging the flow rate for up to 5 sessions using the new port configuration.

  2. Change in Procedure Time [1 year following new port configuration placement]

    The study will compare mean change in procedure time for pheresis sessions with the old system versus pheresis sessions with one of two new configurations.

Secondary Outcome Measures

  1. Change in Use of Tissue Plasminogen Activator [1 year following new port configuration placement]

    The study will compare mean change in use of tissue plasminogen activator for pheresis sessions with the old system versus pheresis sessions with one of two new configurations.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Over the age of 18 years of age.

  • Referred for change from a vortex port to a powerflow port.

  • Previously placed or scheduled placement of one of two configurations of the PowerFlow port

Exclusion Criteria:

  • Unable to read and understand English.

  • Unable to provide informed consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Peter Bream, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT04846374
Other Study ID Numbers:
  • 21-0287
First Posted:
Apr 15, 2021
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Apr 28, 2022