NXT Post-Market Clinical Follow-up

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06336304

Enrollment

163

Registered

2024-03-28

Start date

2024-06-18

Completion date

2026-06-30

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge, Urinary Obstruction

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTUrodynamic procedure

Urodynamic procedure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assess NXT system performance	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?
Assess NXT system safety	120 Minutes	The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.

Secondary

Measure	Time frame	Description
Assess NXT system performance	120 Minutes	Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026