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Clinical Trials/NCT02673944
NCT02673944
Completed
Not Applicable

An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements

Laborie Medical Technologies Inc.0 sites10 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
Laborie Medical Technologies Inc.
Enrollment
10
Primary Endpoint
Accurate Vesical PRessure
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Laborie Medical Technologies Inc.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients normally indicated for urodynamic evaluation

Exclusion Criteria

  • Patients who suffer from bladder infections
  • Patients who suffer from strictures in the urethra

Outcomes

Primary Outcomes

Accurate Vesical PRessure

Time Frame: During a routine urodynamic study (1 hr approx)

To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.

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