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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245695
• Other study ID #: 12-2021
• Status: Recruiting
• Start date: July 12, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Aspira Women's Health
• Contact: Silvana Franco
• Phone: 844-277-4721
• Email: sfranco[@]aspirawh.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain. 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. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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 secondary to chronic pain associated with suspected endometriosis.

Exclusion Criteria:

• Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
• 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.
• Participant has an active pelvic infection or other infections contraindicated for surgery.
• Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.
• Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
• Participant is under 14 years old or over 50 years old

Related Conditions & MeSH terms

• Endometriosis
• Pelvic Pain

Intervention

Other:
• Observational study, no intervention
Observational study, no intervention

Locations

Country	Name	City	State
United States	New Horizons Clinical Trials	Chandler	Arizona
United States	Axia Women's Health	Cincinnati	Ohio
United States	Midtown OBGYN North	Columbus	Georgia
United States	May Grant	Lancaster	Pennsylvania
United States	Womens Health Services of Central Virginia	Lynchburg	Virginia
United States	Arizona Gynecology Consultants	Mesa	Arizona
United States	Reproductive Associates of Delaware (RAD)	Newark	Delaware
United States	Advanced Women's Care Center	Stockbridge	Georgia
United States	Nezhat Surgery for Gynecology/Oncology	Valley Stream	New York

Sponsors (1)

Lead Sponsor	Collaborator
Aspira Women's Health

Country where clinical trial is conducted

United States, 

References & Publications (3)

Gupta D, Hull ML, Fraser I, Miller L, Bossuyt PM, Johnson N, Nisenblat V. Endometrial biomarkers for the non-invasive diagnosis of endometriosis. Cochrane Database Syst Rev. 2016 Apr 20;4(4):CD012165. doi: 10.1002/14651858.CD012165. — View Citation

Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997 May;67(5):817-21. doi: 10.1016/s0015-0282(97)81391-x. No abstract available. — View Citation

Wykes CB, Clark TJ, Khan KS. Accuracy of laparoscopy in the diagnosis of endometriosis: a systematic quantitative review. BJOG. 2004 Nov;111(11):1204-12. doi: 10.1111/j.1471-0528.2004.00433.x. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Secondary	Performance	Examining the performance of the test in patients stratified by pain severity and other clinical factors.	24 months