ApheresisNCT04846374
Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
An observational study of Apheresis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apheresis
- What is being tested?
- PowerPort
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 14 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 20 adults will be enrolled to this study. The study subjects will be recruited from adults who are scheduled to receive or have received a PowerFlow™ Implantable Apheresis IV Port in Vascular Interventional Radiology for their clinical care.
Who may be able to join
- 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
Who cannot join
- Unable to read and understand English.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
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.
- Conditions
- Apheresis
- Being tested
- PowerPort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PowerPortDevice
The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PowerPort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow Rate
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.
Measured: 1 year following new port configuration placement
Change in Procedure Time
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.
Measured: 1 year following new port configuration placement
Secondary outcomes (1)
Change in Use of Tissue Plasminogen Activator
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.
Measured: 1 year following new port configuration placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start26 May 2021
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApheresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Bream, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846374
- Sponsor's protocol ID
- 21-0287
- Status last verified
- May 2023
- First submitted
- 13 Apr 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
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.
PubMed 39105402
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two is Better Than One: A Novel Venous Access System for Intermittent Apheresis
- ClinicalTrials.gov ID
- NCT04846374
- Acronym / sponsor ID
- 21-0287
- Conditions
- Apheresis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PowerPort Subjects | – | Device: PowerPortThis study will involve a chart review of patients at UNC who were referred for change from a vortex port to a powerflow port. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20 adults will be enrolled to this study. The study subjects will be recruited from adults who are scheduled to receive or have received a PowerFlow™ Implantable Apheresis IV Port in Vascular Interventional Radiology for their clinical care.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to read and understand English.
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PowerPortThe study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations. | Device | PowerPort Subjects |
Primary outcome
Change in Flow Rate
Time frame: 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.
Change in Procedure Time
Time frame: 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.
1 secondary outcome
Change in Use of Tissue Plasminogen Activator
Time frame: 1 year following new port configuration placement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 39105402Howlett 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.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bream, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apheresis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flow Rate (time frame: 1 year following new port configuration placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04846374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.