Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12

May 18, 2026 updated by: Essentia Health

A Prospective, Randomized Study To Evaluate The Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12 Weeks

Implanted port devices (IPD) play an essential role in the safe administration of cancer treatments by providing a device to safely administer caustic chemotherapy agents. The current recommended frequency of flushing the IPD per manufacturers guidelines is every 4-6 weeks. The purpose of this study is to find out if extending IPD flushes to every 12 weeks is safe and if it is just as effective as every 4 week flushing.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study and potential risks, all participants giving written informed consent will complete port specific histories, assessments and questionnaires within 14 days prior to registration. Eligible, consented participants will be registered to the study and randomized to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for an initial 12 week interval. If study participants agree to the continuation portion of the study, they will continue to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for up to an additional three 12 week cycles.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Albert Lea, Minnesota, United States, 56007
        • Mayo Clinic Health System - Albert Lea
      • Brainerd, Minnesota, United States, 56401
        • Essentia Health St. Joseph's Medical Center
      • Deer River, Minnesota, United States, 56636
        • Essentia Health Deer River Clinic
      • Detroit Lakes, Minnesota, United States, 56501
        • Essentia Health St Mary's Detroit Lakes Clinic
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Duluth Clinic
      • Fosston, Minnesota, United States, 56542
        • Essentia Health Fosston
      • Grand Rapids, Minnesota, United States, 55744
        • Fairview Grand Itasca Clinic & Hospital
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • Hibbing, Minnesota, United States, 55746
        • Fairview Range Medical Center
      • Mankato, Minnesota, United States, 56001
        • Mayo Clinic Health System - Mankato
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • Park Rapids, Minnesota, United States, 56470
        • Essentia Health Park Rapids
      • Princeton, Minnesota, United States, 55371
        • Fairview Northland Medical Center
      • Sandstone, Minnesota, United States, 55072
        • Essentia Health Sandstone
      • Virginia, Minnesota, United States, 55792
        • Essentia Health Virginia Clinic
      • Worthington, Minnesota, United States, 56187
        • Sanford Worthington Medical Center
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Essentia Health Fargo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device.
  • No planned clinical visits for at least 12 weeks.
  • No planned need to access Implanted Port Device within next 12 weeks outside of routine flushing. Potential reasons to access can include but are not limited to lab draw, infusion, IV contrast.
  • No planned removal of IPD within 12 weeks of registration.
  • No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration.
  • Patient Implanted Port Device with documented blood return ≤ 14 days of registration.
  • Ability to read and speak English.
  • Able to give informed consent.

Exclusion Criteria:

  • Allergy to heparin
  • Vulnerable populations: pregnant women, prisoners, mentally handicapped.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 4-week IPD Flushing Schedule
IPD standard maintenance flushes and port assessments every 4 weeks.
Device: Standard IPD Flush Schedule
IPD flush every 4 weeks
Experimental: 12-week IPD Flushing Schedule
IPD standard maintenance flushes and port assessments every 12 weeks.
Device: Reduced IPD Flush Schedule
IPD flush every 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of IPD patency
Time Frame: 12 weeks post randomization
IPD patency without major complication
12 weeks post randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.
Time Frame: Up to 48 weeks post randomization
Rate of IPD patency during long term follow-up
Up to 48 weeks post randomization
Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.
Time Frame: Up to 48 weeks post randomization
Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events
Up to 48 weeks post randomization
Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes
Time Frame: Up to 48 weeks post randomization
Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status.
Up to 48 weeks post randomization
Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes
Time Frame: Up to 48 weeks post randomization
Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale.
Up to 48 weeks post randomization
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes.
Time Frame: Up to 48 weeks post randomization
Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events
Up to 48 weeks post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Essentia Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Minnesota Cancer Clinical Trials Network

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bret Friday, MD, PhD, Essentia Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MNCCTN024
  • EH21C1 (Other Identifier: Essentia Health)
  • EH22738 (Other Identifier: Essentia Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol, statistical plan and consent form will be available on request. Data will be available on aggregate level; data will be deidentified, the full dataset and statistical code will be available upon request

IPD Sharing Time Frame

6 months after study completion and for 36 months

IPD Sharing Access Criteria

A full description of the intended use of the data must be sent to the Project Direct for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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