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

NCT ID: NCT04846374

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2023-04-14

Brief Summary

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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.

Detailed Description

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Conditions

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Apheresis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PowerPort

Intervention Type DEVICE

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

Interventions

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PowerPort

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Bream, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Howlett MS, Hicks K, Park Y, Karafin MS, Bream PR Jr. Use of a novel configuration of ports for patients needing intermittent long-term apheresis. J Clin Apher. 2024 Aug;39(4):e22143. doi: 10.1002/jca.22143.

Reference Type DERIVED
PMID: 39105402 (View on PubMed)

Other Identifiers

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21-0287

Identifier Type: -

Identifier Source: org_study_id

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