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NCT Number: NCT06336304

NXT Post-Market Clinical Follow-up

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urinary Incontinence, Urge Urinary Obstruction Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

All sexes

Study type

Observational

Primary location

Chesapeake Urology Hanover, Hanover, Maryland, United States

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About this study

The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urodynamic procedure

Diagnostic Test

Urodynamic procedure

Primary outcomes

  1. Assess NXT system performance

    Time frame: 120 Minutes

    Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?

  2. Assess NXT system safety

    Time frame: 120 Minutes

    The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.

Secondary outcomes

  1. Assess NXT system performance

    Time frame: 120 Minutes

    Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?

Study contacts

Contact information is provided by the study sponsor or research team.

Adele Campbell

CONTACT

[email protected]

6032558251

Kaitlyn Palm

CONTACT

[email protected]

6128160068

Sponsors and collaborators

Lead sponsor

Laborie Medical Technologies Inc.

Industry

Registry information

Official study title

NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 28, 2024
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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