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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 weeks post randomization

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of IPD patency

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Minnesota Cancer Clinical Trials NetworkUNKNOWN

Essentia HealthLead Sponsor

26 Previous Clinical Trials

107,810 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research venture?

"As per clinicaltrials.gov, this medical research program is not currently admitting participants; its initial posting was on August 1st 2022 and it was most recently updated on July 8th 2022. Nevertheless, there are 5 other studies that require volunteers right now."

Answered by AI

Who else is applying?

What state do they live in?

Minnesota

What site did they apply to?

Essentia Health St. Joseph's Medical Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I don’t have anything wrong with me, just wondering if you needed to test the drug on a healthy patient, I’d be happy to volunteer. Apologies if I wasted your time.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

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

2022. "Safety of Extending The Routine Flushing Of Implanted Port Devices From 4 Weeks To 12". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05454189.

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