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Not recruiting

Observational Study

Sponsor:

Essentia Health

Code:

NCT05454189

Conditions

Maintenance of Implanted Port Devices

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reduced IPD Flush Schedule

Standard IPD Flush Schedule

Study Details

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

Study ID

NCT05454189

Start date

Oct 11, 2022

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 1, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 4-week IPD Flushing Schedule

IPD standard maintenance flushes and port assessments every 4 weeks.

experimental: 12-week IPD Flushing Schedule

IPD standard maintenance flushes and port assessments every 12 weeks.

Interventions

Reduced IPD Flush Schedule

IPD flush every 12 weeks

Standard IPD Flush Schedule

IPD flush every 4 weeks

Primary outcome measure

  • Rate of IPD patency [ Time Frame: 12 weeks post randomization ]

Central Contacts and Locations

More Information

Sponsor

Essentia Health

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Essentia Health on 2026-05-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.