NXT Post-Market Clinical Follow-up

March 21, 2024 updated by: Laborie Medical Technologies Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male, Female and Pediatric subjects who have been medically indicated for UDS testing.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pediatric
Male Adult Obstructive
Male adult incontinence and/or urgency
Female adult obstructive
Female adult incontinence and/or urgency
Adults with neurological co-morbidities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
120 Minutes
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.
120 Minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
120 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laborie Medical Technologies Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXTPMCF-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Bladder, Overactive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe