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Endometriosis and ATR-FTIR Spectroscopy

F

Federal University of Espirito Santo

Status

Enrolling

Conditions

Endometriosis
Endometriomas

Treatments

Diagnostic Test: FTIR spectroscopy analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT06426420
FTIR-ENDOMETRIOSIS

Details and patient eligibility

About

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

Full 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.

Enrollment

600 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female
  • Pelvic pain complain

Exclusion criteria

  • Age under 18 or above 55
  • Lack of informed consent

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

600 participants in 1 patient group

Pelvic Pain
Experimental group
Description:
Patients referred to the gynecology outpatient clinic, with complain of pelvic pain. Positives and negatives for endometriosis will be outlined by an expert gynecologist according to the following criteria: * Pelvic MRI (Magnetic Resonance Imaging) report; * Gynecologic exam; * Clinical symptoms and history; The intervention is the use of the ATR-FTIR Spectrometer in patient's urine samples to develop and validate a tool for detecting endometriosis.
Treatment:
Diagnostic Test: FTIR spectroscopy analysis

Trial contacts and locations

1

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Central trial contact

Valerio G Barauna, PhD

Data sourced from clinicaltrials.gov

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