NCT05454189

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Essentia Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Maintenance of Implanted Port Devices

Interventions

Type	Name	Description
DEVICE	Reduced IPD Flush Schedule	IPD flush every 12 weeks
DEVICE	Standard IPD Flush Schedule	IPD flush every 4 weeks

Timeline

• Start date: 2022-10-11
• Primary completion: 2025-07-01
• Completion: 2025-12-31
• First posted: 2022-07-12
• Last updated: 2025-07-02

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study