Non-muscle-invasive Bladder CancerNCT06678633
T-Control® Safety for Cytostatics Management
A study of Non-muscle-invasive Bladder Cancer, run by Rethink Medical SL.
Trial summary
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-muscle-invasive Bladder Cancer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Feb 2027
- 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
- Men or women aged ≥18 years.
- Patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy.
- Patients requiring recurrent intravesical instillations for their treatment.
- Signed consent agreement.
Who cannot join
- Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
- Inability to read and understand Portuguese or english.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Usability of the T-Control® Catheter in Cytostatics Management: a Pilot Study
The goal of this pilot clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability of T-Control®. The main questions it aims to answer are:
- Does T-Control® lower the rate of spillages occurred during intravesical treatments?
- Is T-Control® a better device in terms of usability during intravesical treatments?
Read more
Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages.
Participants will:
- Undergo intravesical therapy with the 2 devices used in the study (in two seuqencial cycles of intravesical treatment): T-Control® catheter (experimental intervention) or Folysil® silicone catheter (control intervention).
- At the end of the procedure (1-2 hours), the catheter will be removed or changed. During the first visit, patients will be catheterised with the catheter for the randomly assigned intervention, while in the subsequent visit they will be catheterised with the alternate catheter.
- Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation.
- At the end of the study, healthcare proffesionals will evaluate the usability perceived of both devices used for intravesical treatment.
Read the detailed description
This is a comparative, randomised, prospective and crossover pilot study with two arms that aims to compare the T-Control® catheter versus a conventional Foley-type catheter (Folysil®, Colopalst) in bladder cancer patients who require intravesical chemotherapy or immunotherapy treatment, monitoring the patient from the insertion of the catheter until its removal or change (1 to 2 hours) during each of the two visits programmed for the study (one for each treatment).
The general purpose of this pilot study is to determine the feasibility of a clinical study analysing the advantages that T-Control® can provide, compared with usual clinical practice in the participating center, with respect to chemotherapy and immunotherapy administration and waste management in a prospective, randomised, comparative crossover pilot study, in patients with bladder cancer who need intravesical therapy. This will allow to optimise the design, assess whether recruitment and interventions are sufficient to allow the trial to progress, and gather preliminary data with the following objectives:
- To determine the safety of T-Control® versus the usual clinical practice in the participating center, by comparing the rate of accidental spillages due to the catheter in patients that require oncological intravesical treatments.
- To determine and compare the usability of T-Control® versus the usual clinical practice in the participating center.
All those patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy will be invited to participate and will be interviewed in an initial visit, where the inclusion and exclusion criteria will be checked. The patients will receive information about the study, they will decide whether or not they want to participate, they will sign and deliver the written informed consent and they will be included in the study and randomised into one of the two study interventions. In the subsequent visit, patients will receive the treatment with the alternate catheter. Thus, each patient will receive the intravesical oncological treatment with both catheters assessed in the study.
After the end of each treatment the health professionals who have participated, and after giving their informed consent, will be asked to record all the spillages and leakages occurred during the therapy, whereas at the end of the study they will be asked to measure the usability perceived with both types of catheters
- Conditions
- Non-muscle-invasive Bladder Cancer
- Being tested
- T-Control® (experimental), Folysil® (control)
- Keywords
- Intravesical therapy, Inmunotherapy, Chemotherapy, Non-muscle-invasive bladder cancer, Foley catheter, Bladder instillation
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Control® (experimental)Device
Patients will receive intravesical therapy (1-2 hours) through T-Control®, a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end, which has three positions.
Folysil® (control)Device
Patients will receive intravesical therapy (1-2 hours) through Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.
| Study group | Role | What they receive |
|---|---|---|
| T-Control® | Experimental | Patients will be catheterized for intravesical therapy with a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end. Receives: Device: T-Control® (experimental) |
| Folysil® | Active comparator | Patients will be catheterized for intravesical therapy with Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center. Receives: Device: Folysil® (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of accidental spillages
The number of spillages with cytostatics, body fluids or other non-hazardous spillages divided by the number of interventions (intravesical therapy procedures)
Measured: Intravesical therapy procedure (1-2 hours)
Secondary outcomes (2)
General device-usability
The degree of usability perceived by the health professionals involved in the intravesical procedure will be evaluated through the validated USE Questionnaire on more general usability for medical devices.
Measured: Intravesical therapy procedure (1-2 hours)
Specific device-usability
The degree of usability perceived by the health professionals involved in the intravesical procedure will be evaluated through an ad hoc questionnaire on usability during intravesical therapy.
Measured: Intravesical therapy procedure (1-2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-muscle-invasive Bladder CancerStudies 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Comparative, randomised, prospective and crossover pilot study with two arms
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rethink Medical SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tiago Santos, Principal investigator, Champalimaud Clinical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678633
- Sponsor's protocol ID
- RM-TCONTROL-2025-06
- Status last verified
- May 2025
- First submitted
- 5 Nov 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available from the Sponsor upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability of the T-Control® Catheter in Cytostatics Management: a Pilot Study
- ClinicalTrials.gov ID
- NCT06678633
- Acronym / sponsor ID
- RM-TCONTROL-2025-06
- Conditions
- Non-muscle-invasive Bladder Cancer
- Keywords
- Intravesical therapy, Inmunotherapy, Chemotherapy, Non-muscle-invasive bladder cancer, Foley catheter, Bladder instillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rethink Medical SLIndustry (pharma, biotech, devices)
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Nov 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 clinical trial is to know if this study is feasable in terms of design, recruitment and interventions, as well as gather preliminary data to determine if the T-Control® catheter is safer than the conventional Foley-type catheter during intravesical therapy with oncological patients. It will also learn about the usability of T-Control®. The main questions it aims to answer are:
- Does T-Control® lower the rate of spillages occurred during intravesical treatments?
- Is T-Control® a better device in terms of usability during intravesical treatments?
Researchers will compare T-Control® catheter to a conventional Foley-type catheter (Folysil® Silicone catheter, Coloplast) to see if T-Control® reduce the rate of accidental spillages.
Participants will:
- Undergo intravesical therapy with the 2 devices used in the study (in two seuqencial cycles of intravesical treatment): T-Control® catheter (experimental intervention) or Folysil® silicone catheter (control intervention).
- At the end of the procedure (1-2 hours), the catheter will be removed or changed. During the first visit, patients will be catheterised with the catheter for the randomly assigned intervention, while in the subsequent visit they will be catheterised with the alternate catheter.
- Healthcare professionals involved in the procedure will take note of spillages and others adverse events occurred during the intravesical instillation.
- At the end of the study, healthcare proffesionals will evaluate the usability perceived of both devices used for intravesical treatment.
Detailed description
This is a comparative, randomised, prospective and crossover pilot study with two arms that aims to compare the T-Control® catheter versus a conventional Foley-type catheter (Folysil®, Colopalst) in bladder cancer patients who require intravesical chemotherapy or immunotherapy treatment, monitoring the patient from the insertion of the catheter until its removal or change (1 to 2 hours) during each of the two visits programmed for the study (one for each treatment).
The general purpose of this pilot study is to determine the feasibility of a clinical study analysing the advantages that T-Control® can provide, compared with usual clinical practice in the participating center, with respect to chemotherapy and immunotherapy administration and waste management in a prospective, randomised, comparative crossover pilot study, in patients with bladder cancer who need intravesical therapy. This will allow to optimise the design, assess whether recruitment and interventions are sufficient to allow the trial to progress, and gather preliminary data with the following objectives:
- To determine the safety of T-Control® versus the usual clinical practice in the participating center, by comparing the rate of accidental spillages due to the catheter in patients that require oncological intravesical treatments.
- To determine and compare the usability of T-Control® versus the usual clinical practice in the participating center.
All those patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy will be invited to participate and will be interviewed in an initial visit, where the inclusion and exclusion criteria will be checked. The patients will receive information about the study, they will decide whether or not they want to participate, they will sign and deliver the written informed consent and they will be included in the study and randomised into one of the two study interventions. In the subsequent visit, patients will receive the treatment with the alternate catheter. Thus, each patient will receive the intravesical oncological treatment with both catheters assessed in the study.
After the end of each treatment the health professionals who have participated, and after giving their informed consent, will be asked to record all the spillages and leakages occurred during the therapy, whereas at the end of the study they will be asked to measure the usability perceived with both types of catheters
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparative, randomised, prospective and crossover pilot study with two arms
| Arm | Type | Receives |
|---|---|---|
| T-Control® | Experimental | Device: T-Control® (experimental)Patients will be catheterized for intravesical therapy with a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end. |
| Folysil® | Active comparator | Device: Folysil® (control)Patients will be catheterized for intravesical therapy with Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women aged ≥18 years.
- Patients with bladder cancer who require intravesical treatments with chemotherapy or immunotherapy.
- Patients requiring recurrent intravesical instillations for their treatment.
- Signed consent agreement.
Key exclusion criteria (2 listed)
- Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
- Inability to read and understand Portuguese or english.
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 |
|---|---|---|
| T-Control® (experimental)Patients will receive intravesical therapy (1-2 hours) through T-Control®, a new Foley-type silicone catheter with an integrated fluid-control valve into the catheter's distal end, which has three positions. | Device | T-Control® |
| Folysil® (control)Patients will receive intravesical therapy (1-2 hours) through Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center. | Device | Folysil® |
Primary outcome
Rate of accidental spillages
Time frame: Intravesical therapy procedure (1-2 hours)
The number of spillages with cytostatics, body fluids or other non-hazardous spillages divided by the number of interventions (intravesical therapy procedures)
2 secondary outcomes
General device-usability
Time frame: Intravesical therapy procedure (1-2 hours)
Specific device-usability
Time frame: Intravesical therapy procedure (1-2 hours)
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 29 May 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available from the Sponsor upon reasonable request.
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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.
Tiago Santos principal investigator
Champalimaud Clinical Centre
Questions about this trial
What is this clinical trial studying?
A study of Non-muscle-invasive Bladder Cancer, run by Rethink Medical SL.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Max Mòdol (+ 34 654 48 94 36, mmodol@rethinkmedical.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of accidental spillages (time frame: Intravesical therapy procedure (1-2 hours)). 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 29 May 2025.