Comparative Mixed Study of the Foley Catheter With the T-Control® Catheter in Patients With Long-term Catheterization
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a comparative, randomized, controlled pilot study. The main objective of this study is to evaluate the efficacy, comfort, and patient experience in people with long-term bladder catheterization with T-Control® versus patients with a conventional Foley-type catheter.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Man or women equal or over 18 years old
• Patients who require a change of bladder catheter.
• Indication of bladder catheterization for 4 weeks.
• Maintained cognitive and physical capacity for self-monitoring of the T-Control ® catheter valve.
• Agree to participate in the study and sign the informed consent.
Locations
Other Locations
Spain
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario de Canarias
RECRUITING
Santa Cruz De Tenerife
Contact Information
Primary
Max Mòdol Vidal, Msc
mmodol@rethinkmedical.es
+34 654489436
Backup
Clara Armas Moreno, MSc
carmas@rethinkmedical.es
+34 658 46 97 76
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 50
Treatments
Active_comparator: Control arm (Foley catheter)
When randomly allocated to this arm, a conventional Foley-type catheter will be inserted during all the study period (4 weeks). At day 28 after inclusion, the patient will be called for a follow-up visit to remove the catheter.
Experimental: T-Control arm
When randomly allocated to this arm, the T-Control catheter will be inserted during all the study period (4 weeks). At day 28 after inclusion, the patient will be called for a follow-up visit to remove the catheter.
Related Therapeutic Areas
Sponsors
Leads: Rethink Medical SL