Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474845
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-18
Brief Title:
Efficacy of the T-Control Catheter Compared to the Foley-type Catheter in Patients With Long-term Catheterization
Sponsor:
Rethink Medical SL
Organization:
Rethink Medical SL
Study Overview
Official Title:
Multicentre International Randomized Clinical Study to Assess the Efficacy of the T-Control Catheter vs a Conventional Foley-type Catheter
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if the new urinary catheter T-Control allows a reduction in infections associated with urinary catheters and a better quality of life of urinary catheter patients compared to the conventional Foley-type catheter the currently used in clinical practice It will also learn about the safety profile of the T-Control catheter and its cost-effectiveness The main questions it aims to answer are
Does the T-Control catheter lower the number of infections of the patients who need long-term catheterization Does he T-Control catheter implies a better perceived quality of life of long-term catheterization patients
Participants will
Be catheterized with T-Control or Foley catheter Visit the clinic after 4 weeks for checkups fullfill questionnaires and tests Keep a diary of their symptoms and adverse events related to the catheter
Does the T-Control catheter lower the number of infections of the patients who need long-term catheterization Does he T-Control catheter implies a better perceived quality of life of long-term catheterization patients
Participants will
Be catheterized with T-Control or Foley catheter Visit the clinic after 4 weeks for checkups fullfill questionnaires and tests Keep a diary of their symptoms and adverse events related to the catheter
Detailed Description:
This is a comparative randomized controlled multicentric clinical study with two arms in which the T-control catheter is compared with a conventional Foley-type catheter
The main objective of this study is to determine the efficacy of T-Control compared to the conventional Foley-type catheter by comparing the number of CAUTIs both symptomatic and asymptomatic in patients with long-term catheterization While the secondary objectives are to determine the Health-related QoL HRQoL and analyze the self-perceived QoL of catheterized patients as well as the acceptability of the T-Control device patients satisfaction and patients experience framed in the trajectory of the disease to compare the safety profile between T-Control and the conventional Foley-type catheter and the antibiotics used to determine the cost-effectiveness of T-Control versus the conventional Foley-type catheter from the perspective of the hospital and to measure the level of satisfaction of healthcare professionals with the different types of urinary catheters
Follow-up includes both the time of the catheter insertion until its removal or change lasting 4 weeks All the parameters collected during the follow-up visit refer to the 4 weeks during which the patient has had the catheter inserted
The main objective of this study is to determine the efficacy of T-Control compared to the conventional Foley-type catheter by comparing the number of CAUTIs both symptomatic and asymptomatic in patients with long-term catheterization While the secondary objectives are to determine the Health-related QoL HRQoL and analyze the self-perceived QoL of catheterized patients as well as the acceptability of the T-Control device patients satisfaction and patients experience framed in the trajectory of the disease to compare the safety profile between T-Control and the conventional Foley-type catheter and the antibiotics used to determine the cost-effectiveness of T-Control versus the conventional Foley-type catheter from the perspective of the hospital and to measure the level of satisfaction of healthcare professionals with the different types of urinary catheters
Follow-up includes both the time of the catheter insertion until its removal or change lasting 4 weeks All the parameters collected during the follow-up visit refer to the 4 weeks during which the patient has had the catheter inserted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None