Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)
NCT ID: NCT04161716
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-07-07
2021-09-30
Brief Summary
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In the literature, some studies concerning the use of the NIRS method for the study of urodynamics exist. They seem to show a correlation between the data of the urodynamic assessment and the data obtained with the NIRS method. Certain trends seem to be repeated with, for example, an increase in oxyhemoglobin at the beginning of the filling phase and the beginning of the urination phase.
The aim of the study is to analyze the NIRS signal and find correlation with urodynamic data.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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NIRS module
Each patient has a NIRS module during a diagnosis urodynamic assessment provided for by the usual practice.
NIRS recording
Patient has a NIRS module during their urodynamic exam.
Interventions
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NIRS recording
Patient has a NIRS module during their urodynamic exam.
Eligibility Criteria
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Inclusion Criteria
* Male or female ≥ 18 years
* Person affiliated with a social security scheme
* ECBU / BU negative
Exclusion Criteria
* Pregnant or parturient or lactating women
* Refusal of consent
* Contraindications usually provided for the realization of a Urodynamic exam
* Sensory disturbances making the participant insensitive to pain
* Motor or mental disorders that prevent the participant from expressing pain
* Behavioral problems that make the participant excessively agitated or aggressive
* Irritation and / or erythema, or open sore in the area covered by the NIRS
* Half-sitting position impossible
* Tattoo or stretch mark in the lower abdomen or pubic area
* External cutaneous or internal scar in the area covered by the NIRS
* Allergy to a component of the textile part of the device: polyamide, cotton, polyester, elastane, silver, other synthetic materials
* Simultaneous participation in another search
18 Years
ALL
No
Sponsors
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BioSerenity
INDUSTRY
Responsible Party
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Locations
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Rangueil Hospital
Toulouse, , France
Countries
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Other Identifiers
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2019-A02770-57
Identifier Type: -
Identifier Source: org_study_id