Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age14-50
SponsorAspira Women's Health

About this trial

The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is willing and able to provide written informed consent.

Participant is a female aged 14 to 50 years old at time of consent.

Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis

Disqualifiers

Participant is a female in a pre-menarchal state.

Participant is pregnant.

Participant has an active malignancy.

Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.

Trial population

Women scheduled for a gynecologic surgery

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Observational study, no intervention

    Other intervention

    Observational study, no intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Sensitivity and Specificity

The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively

Time frame
24 months

Secondary outcomes

1

Performance

Examining the performance of the test in patients stratified by pain severity and other clinical factors.

Time frame
24 months

Other outcomes

Sponsors and contacts

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