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NCT06336304 Clinical Trial

NXT Post-Market Clinical Follow-up

Urinary Incontinence Clinical Trial

Official title:
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06336304
Other study ID # NXTPMCF-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date December 2025

Study information
Verified date March 2024
Source Laborie Medical Technologies Inc.
Contact Kaitlyn Palm
Phone 6128160068
Email rs.nxtpmcf@laborie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date December 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Laborie Medical Technologies Inc.

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