NXT Post-Market Clinical Follow-up
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
1 other identifier
observational
180
1 country
4
Brief Summary
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
June 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 26, 2025
February 1, 2025
1.4 years
March 21, 2024
February 24, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Assess NXT system performance
Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?
120 Minutes
Assess NXT system safety
The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.
120 Minutes
Secondary Outcomes (1)
Assess NXT system performance
120 Minutes
Study Arms (6)
Pediatric
Male Adult Obstructive
Male Adult Incontinence and/or Overactive Bladder
Female Adult Obstructive
Female Adult Incontinence and/or Overactive Bladder
Adults with Neurological Co-morbidities
Interventions
Urodynamic procedure
Eligibility Criteria
Male, Female and Pediatric subjects who have been medically indicated for UDS testing.
You may qualify if:
- Patients medically indicated for urodynamic study
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
You may not qualify if:
- Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
- Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
- Pregnant women
- Patients with recent (less than 2 weeks) pelvic floor surgery
- Requires use of suprapubic catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Chesapeake Urology Hanover
Hanover, Maryland, 21076, United States
Chesapeake Urology Owing Mills
Owing Mills, Maryland, 21117, United States
Ohio State University
Columbus, Ohio, 43212, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2024
First Posted
March 28, 2024
Study Start
June 18, 2024
Primary Completion
November 1, 2025
Study Completion
December 1, 2025
Last Updated
February 26, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share