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NCT04161716: DETTECH
Study Evaluating the Ability of a NIRS Module to Detect a Urodynamic Variation in Humans (DETTECH)
NA trial testing NIRS recording in Urinary Disorders in 40 participants. Completed in 30 September 2021.
30 September 2021
Quick facts
| Lead sponsor | BioSerenity |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 40 |
| Start date | 7 July 2020 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- NIRS recording
Conditions studied
- Urinary Disorders — all drugs for Urinary Disorders →
- Urinary Incontinence — all drugs for Urinary Incontinence →
- Urinary Bladder Diseases — all drugs for Urinary Bladder Diseases →
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.
Verify or expand the search:
- PubMed search for NCT04161716
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04161716 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioSerenity
- Last refreshed: 8 November 2021
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