Safety of the CytaCoat LIP Foley CatheterEarly Phase 1NCT06242600
Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter
A Early Phase 1 study testing Drainage of the bladder by indwelling Foley catheter in people with Safety of the CytaCoat LIP Foley Catheter and Tolerability of the CytaCoat LIP Foley Catheter, run by CytaCoat AB at 1 site in Sweden.
Trial summary
The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Safety of the CytaCoat LIP Foley Catheter, Tolerability of the CytaCoat LIP Foley Catheter
- What is being tested?
- Drainage of the bladder by indwelling Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 29 Jan 2024to 26 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Will be undergoing a TUR-B procedure.
- Able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study.
- Adults, age 18 to 84 years.
- Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B surgery.
- Be able to understand and comply with the information given in the Patient Consent Form.
Who cannot join
- Vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects.
- Unable to provide informed consent.
- Has a known bacteriuria or a current urinary tract infection.
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy.
- Has an ongoing antibiotic therapy.
- Cannot accommodate a size 12, 14, 16, 18 or 20 Fr Foley catheter or requires a Thiemann tip Foley catheter.
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- Previous enrolment in the present study.
- Simultaneous participation in another clinical study that may impact the primary endpoint.
- Severe non-compliance to protocol as judged by the PI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Single-center Randomized Pilot Study to Evaluate the Safety and Performance of the Novel CytaCoat LIP Foley Catheter When Compared to an Uncoated Foley Catheter
The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.
The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events.
Read more
The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter.
Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire.
Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.
- Conditions
- Safety of the CytaCoat LIP Foley Catheter, Tolerability of the CytaCoat LIP Foley Catheter
- Being tested
- Drainage of the bladder by indwelling Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drainage of the bladder by indwelling Foley catheterDevice
Also called CytaCoat LIP Foley catheter
Drainage of the bladder by transurethral catheterization with an indwelling Foley catheter of patients undergoing a TUR-B procedure and in need of a Foley catheter for up to 24 hrs.
| Study group | Role | What they receive |
|---|---|---|
| CytaCoat LIP Foley catheter | Experimental | CytaCoat LIP Foley catheters will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for up to 24 hrs. Receives: Device: Drainage of the bladder by indwelling Foley catheter |
| Uncoated silicone Foley catheter | Other | Uncoated silicone Foley catheter will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for up to 24 hrs. Receives: Device: Drainage of the bladder by indwelling Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter
Adverse events (AEs) and serious adverse events (SAEs) will be assessed, which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).
Measured: 1 - 10 days
Secondary outcomes (1)
Assessment of the overall performance of the CytaCoat LIP Foley catheter
The functionality of the coated catheter will be assessed by a responsible nurse/physician with the NRS scale (0-10) using questionnaires.
Measured: 1 - 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start29 Jan 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety of the CytaCoat LIP Foley CatheterStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to CytaCoat LIP Foley catheter / uncoated silicone Foley catheter (15 patients in each arm).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CytaCoat AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Andreasson, MD, Principal investigator, Sahlgrenska University Hospital, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242600
- Sponsor's protocol ID
- CIV-23-03-042616
- Other IDs
- CYTA-FOL-1
- Status last verified
- Nov 2024
- First submitted
- 19 Jan 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-center Randomized Pilot Study to Evaluate the Safety and Performance of the Novel CytaCoat LIP Foley Catheter When Compared to an Uncoated Foley Catheter
- ClinicalTrials.gov ID
- NCT06242600
- Acronym / sponsor ID
- CIV-23-03-042616
- Conditions
- Safety of the CytaCoat LIP Foley Catheter, Tolerability of the CytaCoat LIP Foley Catheter
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CytaCoat ABIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 5 Feb 2024 (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 goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.
The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events.
The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter.
Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire.
Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 1:1 to CytaCoat LIP Foley catheter / uncoated silicone Foley catheter (15 patients in each arm).
| Arm | Type | Receives |
|---|---|---|
| CytaCoat LIP Foley catheter | Experimental | Device: Drainage of the bladder by indwelling Foley catheterCytaCoat LIP Foley catheters will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for up to 24 hrs. |
| Uncoated silicone Foley catheter | Other | Device: Drainage of the bladder by indwelling Foley catheterUncoated silicone Foley catheter will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for up to 24 hrs. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Will be undergoing a TUR-B procedure.
- Able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study.
- Adults, age 18 to 84 years.
- Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B surgery.
- Be able to understand and comply with the information given in the Patient Consent Form.
Key exclusion criteria (9 listed)
- Vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects.
- Unable to provide informed consent.
- Has a known bacteriuria or a current urinary tract infection.
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy.
- Has an ongoing antibiotic therapy.
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 |
|---|---|---|
| Drainage of the bladder by indwelling Foley catheterAlso: CytaCoat LIP Foley catheterDrainage of the bladder by transurethral catheterization with an indwelling Foley catheter of patients undergoing a TUR-B procedure and in need of a Foley catheter for up to 24 hrs. | Device | CytaCoat LIP Foley catheter, Uncoated silicone Foley catheter |
Primary outcome
Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter
Time frame: 1 - 10 days
Adverse events (AEs) and serious adverse events (SAEs) will be assessed, which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).
1 secondary outcome
Assessment of the overall performance of the CytaCoat LIP Foley catheter
Time frame: 1 - 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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.
Anders Andreasson, MD principal investigator
Sahlgrenska University Hospital, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Drainage of the bladder by indwelling Foley catheter in people with Safety of the CytaCoat LIP Foley Catheter and Tolerability of the CytaCoat LIP Foley Catheter, run by CytaCoat AB at 1 site in Sweden.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 7 Nov 2024. 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 Sweden. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter (time frame: 1 - 10 days). 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 7 Nov 2024.