NCT06678633Not yet recruiting
T-Control® Safety for Cytostatics Management
Safety and Usability of the T-Control® Catheter in Cytostatics Management: a Pilot Study
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 5 Nov 2024
- Start date
- Nov 2025
- Primary completion date
- Nov 2026
- Lead sponsor
- Rethink Medical SL
- Diseases
- Bladder cancer
- NCT number
- NCT06678633
What you commit to
- Study type: Interventional
- Planned participants: 16
- From Nov 2025 to the primary completion date, Nov 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with difficult catheterisation who require a urologist to perform the catheter insertion.
- Inability to read and understand Portuguese or english.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.