Follow-up on the NXT Urodynamics System for bladder conditions
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
This study is testing how safe and effective the NXT urodynamic system is for patients who need bladder tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Sex | All |
| Sponsor | Laborie Medical Technologies Inc. Industry-sponsored |
| Locations | 4 sites (Hanover, Maryland and 3 other locations) |
| Trial ID | NCT06336304 on ClinicalTrials.gov |
What this trial studies
This observational study aims to confirm the ongoing safety and performance of the NXT urodynamic system in patients who require urodynamic studies. It involves monitoring patients who are medically indicated for these procedures to ensure the device's effectiveness and safety in various urodynamic patient sub-populations. The study will collect data on patient outcomes and experiences to evaluate the system's performance over time.
Who should consider this trial
Good fit: Ideal candidates include patients who are medically indicated for urodynamic studies and can provide informed consent.
Not a fit: Patients with cognitive or psychiatric conditions that hinder communication, active bladder infections, or recent pelvic floor surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of urodynamic procedures for patients with urinary conditions.
How similar studies have performed: Other studies have shown success in confirming the safety and performance of urodynamic systems, making this approach a continuation of established practices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients medically indicated for urodynamic study * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements Exclusion Criteria: * 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
Where this trial is running
Hanover, Maryland and 3 other locations
- Chesapeake Urology Hanover — Hanover, Maryland, United States (Recruiting)
- Chesapeake Urology Owing Mills — Owing Mills, Maryland, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Kaitlyn Palm
- Email: rs.nxtpmcf@laborie.com
- Phone: 6128160068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.