Catheter Caps for Dialysis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Delayed graft function, acute kidney injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to evaluate patient comfort and ease of an investigational device called Catheter Caps Case (C3) attached to the hemodialysis catheter over a 15-minute period. You have been asked to take part in this research because you have been identified as a dialysis patient with a hemodialysis catheter.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

How do catheter caps for dialysis differ from other treatments?

The catheter caps for dialysis are unique because they focus on preventing infections and maintaining catheter function, which is crucial for patients undergoing dialysis. Unlike other treatments that may require surgical intervention or replacement of the catheter, these caps offer a non-invasive solution to enhance the safety and effectiveness of dialysis treatment. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for dialysis patients who use a hemodialysis catheter. It's designed to assess how comfortable and easy it is to use a new device called Catheter Caps Case (C3) over a short period.

Inclusion Criteria

Patients with tunneled dialysis catheter that will not be removed in the next 90 days

I am a patient receiving dialysis, either at home or in a center.

Exclusion Criteria

Allergies to the BioMed Elastic 50A Resin

Patients with non-tunneled catheter

I am currently experiencing acute kidney injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use the Catheter Caps Case (C3) attached to the hemodialysis catheter for evaluation over a 15-minute period

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or issues following the use of the Catheter Caps Case

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Catheter Caps Case (C3)

Trial Overview The study is testing the Catheter Caps Case (C3), which attaches to the hemodialysis catheter. The focus is on patient comfort and ease of use during a brief, 15-minute evaluation period.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. Singapore pubmed.ncbi.nlm.nih.gov

Revision of dysfunctional Tenckhoff catheters by laparoscopic technique in continuous ambulatory peritoneal dialysis patients. [2016]

2. Canada pubmed.ncbi.nlm.nih.gov

Freedom Set II--a Y-set CAPD system with a novel design. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Crystalline Micro-Sized Carbonated Apatites: Chemical Anisotropy of the Crystallite Surfaces, Biocompatibility, Osteoconductivity, and Osteoinductive Effect Enhanced by Poly(ethylene phosphoric acid). [2023]

4. England pubmed.ncbi.nlm.nih.gov

A novel retroauricular fixed port for hemodialysis: surgical procedure and preliminary results of the clinical investigation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Direct Pulp Capping with Calcium Hydroxide, Mineral Trioxide Aggregate, and Biodentine in Permanent Young Teeth with Caries: A Randomized Clinical Trial. [2022]