Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571058
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
B3 Buddy for Securing Urinary Drainage Bag to Patient While Walking
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Testing of a Urinary Drainage Bag Securement Device to Improve Patient and Clinician Ambulation Experiences
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial tests how well the Bag Below Bladder B3 Buddy device works in securing urinary drainage bags while walking Keeping a urinary drainage bag below the bladder is the standard of care to maintain urine flow and prevent urine from backing up into the bladder Despite the use of modern urinary drainage bags for over 60 years workarounds including hooking the bag into pants pockets are being used to secure the bags while walking The B3 Buddy may help keep the urinary drainage bag at the proper level for drainage while walking
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the acceptability of the B3 Buddy from the patients perspective
II To evaluate the usability of the B3 Buddy from the clinicians perspective
OUTLINE Patients are assigned to 1 of 2 groups
PATIENTS Patients receive a short instructional session wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study
CLINICIANS Clinicians receive a short instructional session secure the urinary drainage bag to the patient using the B3 Buddy device Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study
I To evaluate the acceptability of the B3 Buddy from the patients perspective
II To evaluate the usability of the B3 Buddy from the clinicians perspective
OUTLINE Patients are assigned to 1 of 2 groups
PATIENTS Patients receive a short instructional session wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study
CLINICIANS Clinicians receive a short instructional session secure the urinary drainage bag to the patient using the B3 Buddy device Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None