- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02673944
Portable Pves Study
May 17, 2016 updated by: Laborie Medical Technologies Inc.
An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients normally indicated for urodynamic evaluation
Exclusion Criteria:
- Patients who suffer from bladder infections
- Patients who suffer from strictures in the urethra
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peritron+
Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter
|
Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During a routine urodynamic study (1 hr approx)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2016
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
January 29, 2016
First Submitted That Met QC Criteria
February 1, 2016
First Posted (Estimate)
February 4, 2016
Study Record Updates
Last Update Posted (Estimate)
June 24, 2016
Last Update Submitted That Met QC Criteria
May 17, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLUS-PVES-01
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.
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