T-Control® Safety for Cytostatics Management

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?

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-muscle-invasive Bladder Cancer
• Intervention / Treatment: Device: T-Control® (experimental); Device: Folysil® (control)

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 Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Max Mòdol; Phone Number: + 34 654 48 94 36; Email: mmodol@rethinkmedical.es
• Study Contact Backup: Name: Manuel Luque; Phone Number: + 34 646 30 76 42; Email: mluque@rethinkmedical.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T-Control®; 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.	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.
Active Comparator: Folysil®; Patients will be catheterized for intravesical therapy with Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.	Device: Folysil® (control); Patients will receive intravesical therapy (1-2 hours) through Folysil® Silicone catheter (Coloplast), the usual clinical practice in the participating center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Intravesical therapy procedure (1-2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Intravesical therapy procedure (1-2 hours)

Collaborators and Investigators

• Sponsor: Rethink Medical SL
• Investigators: Principal Investigator: Tiago Santos, Champalimaud Clinical Centre

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chemotherapy; Non-muscle-invasive bladder cancer; Inmunotherapy; Bladder instillation; Foley catheter; Intravesical therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: RM-TCONTROL-2025-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication will be available from the Sponsor upon reasonable request.
• IPD Sharing Time Frame: Within one year from the completion of the clinical investigation or three months after its early termination or temporary cessation. When, for scientific reasons, would not possible to submit the clinical research report within one year after completion of the research, it will be submitted as soon as it is available.
• IPD Sharing Access Criteria: Available from the Sponsor upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No