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NCT06426420 Clinical Trial

Endometriosis and ATR-FTIR Spectroscopy

Endometriosis Clinical Trial

Official title:
Detection of Endometriosis Using ATR-FTIR Spectroscopy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06426420
Other study ID # FTIR-ENDOMETRIOSIS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date April 29, 2026

Study information
Verified date May 2024
Source Federal University of Espirito Santo
Contact Valerio G Barauna, PhD
Phone +5527996892407
Email barauna2@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine.

Description:

Endometriosis is a chronic gynecological disease that is considered debilitating and multifactorial. Its diagnosis is invasive and can be prolonged due to non-specific symptoms and erroneous or late investigations, which can lead to delays and impair the provision of adequate treatment. ATR-FTIR Spectroscopy is a non-invasive technique with the capability to identify the chemical composition and molecular changes of samples through its interaction with mid-infrared radiation. The aim of this work is to develop a rapid test for the detection of endometriosis in urine samples using spectroscopy and machine learning algorithms.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date April 29, 2026
Est. primary completion date April 29, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Female - Pelvic pain complain Exclusion Criteria: - Age under 18 or above 55 - Lack of informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• FTIR spectroscopy analysis
ATR-FTIR Spectroscopy analysis combined with machine learning algorithms.

Locations
Country Name City State
Brazil University Hospital Cassiano Antonio Moraes at Federal Univeristy Of Espírito Santo Vitória Espírito Santo

Sponsors (2)
Lead Sponsor Collaborator
Federal University of Espirito Santo Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spectroscopy Reliability (diagnostic metrics) The primary outcome is the evaluation of specificity, sensitivity and accuracy of the diagnostic. Acceptable diagnostic metrics must be comparable to MRI, which will demonstrate if spectroscopy can discriminate between negative and positive endometriosis patients. 1 year
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