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Extended Flushing Interval for Implanted Port Device Maintenance

N/A
Recruiting
Led By Bret Friday, MD, PhD
Research Sponsored by Essentia Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No Deep Vein Thrombosis or significant Implanted Port Device complication within ≤ 4 weeks of registration.
Hematology/Oncology patients ≥ 18 years old with an Implanted Port Device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks post randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether it's safe to extend the time between flushes for a type of cancer treatment.

Who is the study for?
This trial is for adult hematology/oncology patients with an implanted port device (IPD) used for chemotherapy, who haven't had complications like Deep Vein Thrombosis in the last 4 weeks. Participants should not need to use their IPD outside of routine flushing for the next 12 weeks and must be able to give informed consent and understand English.
What is being tested?
The study is testing if it's safe to extend the routine flushing of implanted port devices from every 4 weeks to every 12 weeks. This could potentially make maintenance easier without compromising safety or effectiveness.
What are the potential side effects?
Since this trial involves a change in maintenance schedule rather than medication, side effects are not expected as part of the intervention being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't had a serious blood clot or major issues with an implanted port in the last 4 weeks.
Select...
I am 18 or older with a port device implanted for cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of IPD patency
Secondary study objectives
Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes
Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization.
Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 12-week IPD Flushing ScheduleExperimental Treatment1 Intervention
IPD standard maintenance flushes and port assessments every 12 weeks.
Group II: 4-week IPD Flushing ScheduleActive Control1 Intervention
IPD standard maintenance flushes and port assessments every 4 weeks.

Find a Location

Who is running the clinical trial?

Minnesota Cancer Clinical Trials NetworkUNKNOWN
Essentia HealthLead Sponsor
26 Previous Clinical Trials
106,549 Total Patients Enrolled
Bret Friday, MD, PhDPrincipal InvestigatorEssentia Health

Media Library

Reduced IPD Flush Schedule Clinical Trial Eligibility Overview. Trial Name: NCT05454189 — N/A
Maintenance of Implanted Port Devices Research Study Groups: 4-week IPD Flushing Schedule, 12-week IPD Flushing Schedule
Maintenance of Implanted Port Devices Clinical Trial 2023: Reduced IPD Flush Schedule Highlights & Side Effects. Trial Name: NCT05454189 — N/A
Reduced IPD Flush Schedule 2023 Treatment Timeline for Medical Study. Trial Name: NCT05454189 — N/A
Maintenance of Implanted Port Devices Patient Testimony for trial: Trial Name: NCT05454189 — N/A
~55 spots leftby Apr 2025
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