T-DOC® NXT Clinical Investigation NCT03615001

Clinical Trial Details — Status: Completed

Study information
Verified date	May 2020
Source	Laborie Medical Technologies Inc.
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Recruitment information / eligibility
Status	Completed
Enrollment	20
Est. completion date	October 4, 2018
Est. primary completion date	October 4, 2018
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	21 Years and older
Eligibility	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

Device:
• TDOC NXT
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Locations
Country	Name	City	State
United States	Franklin Square Hospital/White Marsh	Baltimore	Maryland

Sponsors *(1)*
Lead Sponsor	Collaborator
Laborie Medical Technologies Inc.

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months
Primary	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.	2 months

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