NXT Post-Market Clinical Follow-up

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLaborie Medical Technologies Inc.

About this trial

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

Eligibility criteria

Qualifiers

Patients medically indicated for urodynamic study

Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Urodynamic procedure

Treatment groups

180 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.