Dialysis Catheter Caps Case Feasibility Study

NCT06905080 | Active Not Recruiting FDA Device

• 1 other identifier: 24-010774
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sterile Catheter; Dialysis Catheter; Dialysis; Catheter-related Bloodstream Infections

Keywords

Sterile Catheter; catheter-related bloodstream infections; Catheter Caps Case; infection control; C3; Dialysis Catheter Caps Case; Dialysis Catheter; Dialysis; Catheter

Outcome Measures

Primary Outcomes (1)

• To evaluate the ease and structural integrity of the Catheter Caps Case (C3)

  The feasibility of the catheter cap will be assessed by evaluating its ease of use and structural integrity. This includes measuring the time required for secure placement and removal compared to traditional gauze and tape, as well as obtaining standardized usability ratings from healthcare providers. Additionally, the study will track the incidence of accidental catheter dislodgement during routine cap changes to determine whether the cap provides enhanced stability.

  1 Day

Interventions

Catheter Caps Case (C3) DEVICE

The nursing team will then assess the participant's catheter, catheter site, and lumens. The C3 device will be placed on the distal lumens and hub caps of the participant's hemodialysis catheter using clean technique and left in place for approximately 15 minutes. During this time, the participant will be asked to lay, sit, and stand while wearing the C3 device. The RN will stay with the participant during the entire time and will write down any comments or requests regarding the C3 made by the participant. After 15 minutes, the nursing team will remove the C3 device and reassess the condition of the catheter site and lumens, noting any changes. Finally, the participant will complete a 10 item post- intervention survey, developed by the study team and evaluated for face validity by all members of the team to provide feedback on the design of the C3 device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with tunneled dialysis catheter that will not be removed in the next 90 days.
• Patients from the home dialysis program or in-center (outpatient dialysis) patient population.
• Patients who are age 18 years or older

You may not qualify if:

• Patient-delayed graft function (DGF)
• Acute kidney injury patients
• Patients with non-tunneled catheter
• Allergies to the BioMed Elastic 50A Resin

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic (Florida)

Jacksonville, Florida, 32224, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 1, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)