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

NCT05454189 | Recruiting DMC FDA Device

• 3 other identifiers: MNCCTN024EH21C1EH22738
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Maintenance of Implanted Port Devices

Outcome Measures

Primary Outcomes (1)

• Rate of IPD patency

  IPD patency without major complication

  12 weeks post randomization

Secondary Outcomes (5)

• Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization.

  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.

  Up to 48 weeks post randomization

• Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes

  Up to 48 weeks post randomization

• Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes

  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.

  Up to 48 weeks post randomization

Study Arms (2)

4-week IPD Flushing Schedule

ACTIVE COMPARATOR

IPD standard maintenance flushes and port assessments every 4 weeks.

Device: Standard IPD Flush Schedule

12-week IPD Flushing Schedule

EXPERIMENTAL

IPD standard maintenance flushes and port assessments every 12 weeks.

Device: Reduced IPD Flush Schedule

Interventions

Reduced IPD Flush Schedule DEVICE

IPD flush every 12 weeks

12-week IPD Flushing Schedule

Standard IPD Flush Schedule DEVICE

IPD flush every 4 weeks

4-week IPD Flushing Schedule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Essentia Health: lead
• Minnesota Cancer Clinical Trials Network: collaborator

Study Sites (17)

Mayo Clinic Health System - Albert Lea

Albert Lea, Minnesota, 56007, United States

RECRUITING

Essentia Health St. Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

RECRUITING

Essentia Health Deer River Clinic

Deer River, Minnesota, 56636, United States

RECRUITING

Essentia Health St Mary's Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

RECRUITING

Essentia Health Duluth Clinic

Duluth, Minnesota, 55805, United States

RECRUITING

Essentia Health Fosston

Fosston, Minnesota, 56542, United States

RECRUITING

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, 55744, United States

RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

RECRUITING

Fairview Range Medical Center

Hibbing, Minnesota, 55746, United States

RECRUITING

Mayo Clinic Health System - Mankato

Mankato, Minnesota, 56001, United States

RECRUITING

Monticello Cancer center

Monticello, Minnesota, 55362, United States

RECRUITING

Essentia Health Park Rapids

Park Rapids, Minnesota, 56470, United States

RECRUITING

Fairview Northland Medical Center

Princeton, Minnesota, 55371, United States

RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

RECRUITING

Sanford Worthington Medical Center

Worthington, Minnesota, 56187, United States

RECRUITING

Essentia Health Fargo

Fargo, North Dakota, 58103, United States

RECRUITING

Study Officials

• Bret Friday, MD, PhD

  Essentia Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bret Friday, MD, PhD

CONTACT

218-786-3625; bret.friday@essentiahealth.org

Tammie Mlodozyniec

CONTACT

218-786-1018; tammie.mlodozyniec@essentiahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective, randomized study to determine the non-inferiority of every 12 week IPD flushes compared to every 4 week flushes in participants on an IPD maintenance flush schedule.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 12, 2022
• Study Start: October 11, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after study completion and for 36 months
• 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.

Locations

US (17)