T-DOC® NXT Clinical Investigation

• Sponsor: Laborie Medical Technologies Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03615001
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Incontinence, Urge	Device: TDOC NXT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
• Actual Study Start Date: Jul 18, 2018
• Actual Primary Completion Date: Oct 4, 2018
• Actual Study Completion Date: Oct 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Urodynamics Arm	Device: TDOC NXT; Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies

Outcome Measures

Primary Outcome Measures

1. The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults. [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.

2. The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franklin Square Hospital/White Marsh	Baltimore	Maryland	United States	21237

Sponsors and Collaborators

• Laborie Medical Technologies Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 26, 2018
• Statistical Analysis Plan - Nov 8, 2018

More Information

Publications

None provided.

• Responsible Party: Laborie Medical Technologies Inc.
• ClinicalTrials.gov Identifier: NCT03615001
• Other Study ID Numbers: TDOC-NXT-01
• First Posted: Aug 3, 2018
• Last Update Posted: Jun 9, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Urinary Incontinence, Urge

Study Results

Participant Flow

Arm/Group Title	Urodynamics Arm
Arm/Group Description	Urodynamic testing and data collection (per protocol) using the TDOC NXT catheters
Period Title: Overall Study
STARTED	20
COMPLETED	20
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Urodynamics Arm
Arm/Group Description	TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 45%
>=65 years	11 55%
Sex: Female, Male (Count of Participants)
Female	17 85%
Male	3 15%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urodynamics Arm
Arm/Group Description	TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Measure Participants	20
Count of Participants [Participants]	20 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Urodynamics Arm
Arm/Group Description	TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
Measure Participants	20
Count of Participants [Participants]	20 100%

Adverse Events

Time Frame	Through study completion (average of one day)
Arm/Group Title	Urodynamics Arm
Arm/Group Description	TDOC NXT: Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
All Cause Mortality
	Urodynamics Arm
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Urodynamics Arm
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Urodynamics Arm
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.