Dialysis Catheter Caps Case Feasibility Study
NCT06905080 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-01-22
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
- Catheter-related Bloodstream Infections
- Dialysis Catheter
- Dialysis
Interventions
- DEVICE
-
Catheter Caps Case (C3)
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.
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-13
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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