Actively Recruiting
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
Led by Laborie Medical Technologies Inc. · Updated on 2026-05-15
180
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to confirm the ongoing safety and performance of the NXT Urodynamics System in patients who require urodynamic studies for various urinary conditions. It focuses on patient groups including pediatric patients, adults with urinary incontinence or obstruction, overactive bladder, and those with neurological co-morbidities. The study is observational and evaluates the system in real-world clinical settings. Participants undergo the NXT urodynamic procedure, a diagnostic test used to assess bladder and urinary function. The study includes several patient sub-populations such as pediatric patients, male and female adults with obstructive or incontinence conditions, and adults with neurological issues. The study tracks the system's performance and safety during these procedures. During the study, researchers assess the performance and safety of the NXT system within a 120-minute evaluation period. Participants are monitored for any complications or issues related to the diagnostic procedure. The study involves patient questionnaires and informed consent processes to ensure accurate communication and data collection, with follow-up and data analysis continuing until March 2027.
CONDITIONS
Brief Title
NXT Post-Market Clinical Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients medically indicated for urodynamic study
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
You will not qualify if you...
- 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 asymptomatic bacteria)
- Pregnant women
- Patients with recent (less than 2 weeks) pelvic floor surgery
- Requires use of suprapubic catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 120 minutes
Participants undergo a urodynamic procedure to assess the performance and safety of the NXT urodynamic system.
1 visit (in-person)
Duration - Up to study completion
Participants are observed following the diagnostic evaluation to monitor outcomes related to the NXT urodynamic system.
Visit schedule varies depending on participant condition
Trial Site Locations
Total: 5 locations
1
Chesapeake Urology Hanover
Hanover, Maryland, United States, 21076
Actively Recruiting
2
Chesapeake Urology Owing Mills
Owing Mills, Maryland, United States, 21117
Actively Recruiting
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Not Yet Recruiting
4
Ohio State University
Columbus, Ohio, United States, 43212
Actively Recruiting
5
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
K
Kaitlyn Palm
A
Adele Campbell
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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