Back to resultsT-DOC® NXT Clinical Investigation
Primary Purpose
Incontinence, Urge
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TDOC NXT
Sponsored by
About this trial
This is an interventional other trial for Incontinence, Urge
Eligibility Criteria
Inclusion Criteria:
- Male and Female (Adult age 21+)
- Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.
Exclusion Criteria:
- Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
- Patients who are pregnant
- Patients with recent (less than 2 weeks) pelvic floor surgery
- Patients who require the use of a suprapubic catheter
- Patients with significant cognitive deficiency that prevent the patient from giving informed consent
Sites / Locations
- Franklin Square Hospital/White Marsh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Urodynamics Arm
Arm Description
Outcomes
Primary Outcome Measures
The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is safe for a positive outcome and a maximum of 40.
The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is effective for a positive outcome and a maximum of 40.
Secondary Outcome Measures
Full Information
NCT ID
NCT03615001
First Posted
July 30, 2018
Last Updated
May 27, 2020
Sponsor
Laborie Medical Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03615001
Brief Title
T-DOC® NXT Clinical Investigation
Official Title
Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laborie Medical Technologies Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urge
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Urodynamics Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TDOC NXT
Intervention Description
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Primary Outcome Measure Information:
Title
The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.
Description
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is safe for a positive outcome and a maximum of 40.
Time Frame
2 months
Title
The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.
Description
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is effective for a positive outcome and a maximum of 40.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and Female (Adult age 21+)
Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.
Exclusion Criteria:
Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
Patients who are pregnant
Patients with recent (less than 2 weeks) pelvic floor surgery
Patients who require the use of a suprapubic catheter
Patients with significant cognitive deficiency that prevent the patient from giving informed consent
Facility Information:
Facility Name
Franklin Square Hospital/White Marsh
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
12. IPD Sharing Statement
Learn more about this trial
T-DOC® NXT Clinical Investigation
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