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NCT04161716: DETTECH

Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)

Completed NA Last updated 8 November 2021
What this trial tests

NA trial testing NIRS recording in Urinary Disorders in 40 participants. Completed in 30 September 2021.

Timeline
7 July 2020
Primary endpoint
30 September 2021
30 September 2021

Quick facts

Lead sponsorBioSerenity
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposedevice feasibility
Enrollment40
Start date7 July 2020
Primary completion30 September 2021
Estimated completion30 September 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

BioSerenity

Who can join

18 and older, any sex, with Urinary Disorders or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

NIRS technology is therefore a technique that exploits the different absorption properties of oxygenated and deoxygenated hemoglobin to evaluate the degree of tissue oxygenation. This hemodynamic response is measured in a completely non-invasive and silent manner, by the simple emission of light passing through different layers of biological tissue. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other BioSerenity trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04161716.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing