Trial Outcomes & Findings for T-DOC® NXT Clinical Investigation (NCT NCT03615001)

NCT ID: NCT03615001

Last Updated: 2020-06-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2020-06-09

Participant Flow

Participant milestones

Measure	Urodynamics Arm Urodynamic testing and data collection (per protocol) using the TDOC NXT catheters
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Urodynamics Arm n=20 Participants TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=20 Participants
Age, Categorical >=65 years	11 Participants n=20 Participants
Sex: Female, Male Female	17 Participants n=20 Participants
Sex: Female, Male Male	3 Participants n=20 Participants

PRIMARY outcome

Timeframe: 2 months

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.

Outcome measures

Measure	Urodynamics Arm n=20 Participants TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.	20 Participants

PRIMARY outcome

Timeframe: 2 months

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.

Outcome measures

Measure	Urodynamics Arm n=20 Participants TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.	20 Participants

Adverse Events

Urodynamics Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Gallone, Clinical Research Manager

Laborie

Phone: 9056121170

Email: sgallone@laborie.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60