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T-Control® Safety for Cytostatics Management

NCT06678633 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-05-29

No results posted yet for this study

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. 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

  • Non-muscle-invasive Bladder Cancer

Interventions

DEVICE

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

Folysil® (control)

Patients will receive intravesical therapy (1-2 hours) through Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.

Sponsors & Collaborators

  • Rethink Medical SL

    lead INDUSTRY

Principal Investigators

  • Tiago Santos · Champalimaud Clinical Centre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2026-11-30
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678633 on ClinicalTrials.gov