Sterile CatheterNCT06905080
Dialysis Catheter Caps Case Feasibility Study
A study testing Catheter Caps Case (C3) in people with Sterile Catheter and Catheter-related Bloodstream Infections, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sterile Catheter, Catheter-related Bloodstream Infections, Dialysis Catheter
- What is being tested?
- Catheter Caps Case (C3)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient-delayed graft function (DGF)
- Acute kidney injury patients
- Patients with non-tunneled catheter
- Allergies to the BioMed Elastic 50A Resin
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Tunneled hemodialysis catheters are commonly used to administer dialysis to patients with kidney failure to remove excess fluid and waste from the blood. Traditionally, the maintenance and protection of these catheters involves the use of gauze and tape to secure the catheter and cover the double lumen and caps. While this method is widely practiced, it has several drawbacks that can affect both patient outcomes and healthcare efficiency.
Firstly, the use of gauze and tape can be uncomfortable for patients. The adhesive nature of the tape can cause skin irritation and allergic reactions, in addition the gauze can impede visualization of the entire length of the catheter. Additionally, the process of routine changing gauze and tape is time-consuming for healthcare providers and can increase the risk of catheter dislodgment during or catheter caps disconnection during removal of tape gauze combination.
Another significant concern is infection control. Gauze and tape do not provide an optimal sterile barrier, which can lead to an increased risk of catheter-related bloodstream infections (CRBSIs). These infections are associated with prolonged hospital stays, higher hospital healthcare costs, and increased patient mobility and mortality.
The catheter caps case was developed to address these issues by providing a more secure and sterile alternative to gauze and tape. The case is designed to cover the catheter's double lumen and end caps, offering added protection and stability. Its innovative design aims to reduce the risk of accidental dislodgement, enhance infection control, and improve overall patient comfort by eliminating the need for gauze and adhesive tape.
- Being tested
- Catheter Caps Case (C3)
- Keywords
- Sterile Catheter, catheter-related bloodstream infections, Catheter Caps Case, infection control, C3, Dialysis Catheter Caps Case, Dialysis Catheter, Dialysis, Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterile CatheterStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie R. Jenkins, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905080
- Sponsor's protocol ID
- 24-010774
- Status last verified
- Jan 2026
- First submitted
- 18 Mar 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At this time, it has not been determined whether individual participant data (IPD) will be shared. The decision will depend on factors such as regulatory requirements, ethical considerations, and sponsor policies. If IPD sharing is implemented, appropriate safeguards will be in place to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Catheter Caps Case Feasibility Study
- ClinicalTrials.gov ID
- NCT06905080
- Acronym / sponsor ID
- 24-010774
- Keywords
- Sterile Catheter, catheter-related bloodstream infections, Catheter Caps Case, infection control, C3, Dialysis Catheter Caps Case, Dialysis Catheter, Dialysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tunneled hemodialysis catheters are commonly used to administer dialysis to patients with kidney failure to remove excess fluid and waste from the blood. Traditionally, the maintenance and protection of these catheters involves the use of gauze and tape to secure the catheter and cover the double lumen and caps. While this method is widely practiced, it has several drawbacks that can affect both patient outcomes and healthcare efficiency.
Firstly, the use of gauze and tape can be uncomfortable for patients. The adhesive nature of the tape can cause skin irritation and allergic reactions, in addition the gauze can impede visualization of the entire length of the catheter. Additionally, the process of routine changing gauze and tape is time-consuming for healthcare providers and can increase the risk of catheter dislodgment during or catheter caps disconnection during removal of tape gauze combination.
Another significant concern is infection control. Gauze and tape do not provide an optimal sterile barrier, which can lead to an increased risk of catheter-related bloodstream infections (CRBSIs). These infections are associated with prolonged hospital stays, higher hospital healthcare costs, and increased patient mobility and mortality.
The catheter caps case was developed to address these issues by providing a more secure and sterile alternative to gauze and tape. The case is designed to cover the catheter's double lumen and end caps, offering added protection and stability. Its innovative design aims to reduce the risk of accidental dislodgement, enhance infection control, and improve overall patient comfort by eliminating the need for gauze and adhesive tape.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patient-delayed graft function (DGF)
- Acute kidney injury patients
- Patients with non-tunneled catheter
- Allergies to the BioMed Elastic 50A Resin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
To evaluate the ease and structural integrity of the Catheter Caps Case (C3)
Time frame: 1 Day
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided. At this time, it has not been determined whether individual participant data (IPD) will be shared. The decision will depend on factors such as regulatory requirements, ethical considerations, and sponsor policies. If IPD sharing is implemented, appropriate safeguards will be in place to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter Caps Case (C3) in people with Sterile Catheter and Catheter-related Bloodstream Infections, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the ease and structural integrity of the Catheter Caps Case (C3) (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.