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Diagnosing endometriosis using exhaled breath analysis by Electronic Nose: a pilot study

Diagnosing endometriosis using exhaled breath analysis by Electronic Nose: a pilot study - Endometriosis eNose pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52727
Enrollment
80
Registered
2021-03-29
Start date
2022-10-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometriose Endometriosis

Interventions

None listed

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Cases: - Aged between 18-40 years. - (1) diagnosed with endometriosis by laparoscopy OR (2) diagnosed with deep invasive endometriosis (DIE) by MRI after positive gynecological examination and subsequent ultrasound. Controls: - Aged between 18-40 years. - Conformed absence of endometriosis by laparoscopy (e.g. sterilization, extra-uterine pregnancy, diagnostic in case of infertility) or laparotomy (e.g. cesarean section).

Exclusion criteria

Exclusion criteria: - Underage women (40 years - Pregnancy or currently breastfeeding - Diagnosed adenomyosis without endometriosis - Alcohol consumption

Design outcomes

Primary

MeasureTime frame
The primary outcome consist of exhaled breath profiles obtained by sampling exhaled breath using eNose technology. These profiles form a characteristic fingerprint of the Volatile Organic Compounds (VOC*s) present in exhaled breath. The profiles of both endometriosis patients and healthy controls will be analysed and compared to determine the sensitivity and specificity of the eNose technology in diagnosing endometriosis.

Secondary

MeasureTime frame
The sensitivity and specificity of the eNose technology in differentiating between early and advanced stages of endometriosis.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)