T-DOC® NXT Clinical Investigation

NCT03615001 | Completed Results FDA Device

• 1 other identifier: TDOC-NXT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Incontinence, Urge

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Urodynamics Arm

EXPERIMENTAL

Device: TDOC NXT

Interventions

TDOC NXT DEVICE

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

Urodynamics Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female (Adult age 21+)
• Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laborie Medical Technologies Inc.: lead

Study Sites (1)

Franklin Square Hospital/White Marsh

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Gallone, Clinical Research Manager
• Organization: Laborie

sgallone@laborie.com

9056121170

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: July 18, 2018
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Locations

US (1)