Clinical trial · Interventional
T-Control® Safety for Cytostatics Management
Safety and Usability of the T-Control® Catheter in Cytostatics Management: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle-invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Folysil® (control) | Device | — | UNRESOLVED |
| T-Control® (experimental) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- T-Control®
- description
- 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.
- interventionNames
- Device: T-Control® (experimental)
- type
- ACTIVE_COMPARATOR
- label
- Folysil®
- description
- Patients will be catheterized for intravesical therapy with Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.
- interventionNames
- Device: Folysil® (control)
Primary outcomes (1)
- measure
- Rate of accidental spillages
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with difficult catheterisation who require a urologist to perform the catheter insertion. * Inability to read and understand Portuguese or english.
References
Publications (0)
Data not yet available