This study is testing a way to diagnose endometriosis using a uterine tissue biopsy (similar to a pap smear) as opposed to undergoing laparoscopy surgery. The tissue is sent to lab for cellular analysis with a proprietary AI (artificial intelligence) technology.
This study involves 2 visits to the site and possibly as outpatient surgical center, and the participant will be involved in the for as little as 1 day to as much as 60 days, mainly depending on scheduling of laparoscopy. Eligible participants in the active group will have history of endometriosis and will be having a laparoscopy for diagnosis within the next few weeks. Eligible participants in the control group will have no history of endometriosis but will need or have recently had a laparoscopy surgical procedure for a reasons such as tubal ligation. The participant will have an uterine biopsy (similar to a pap smear) in the physician's office before the laparoscopy. The biopsied tissue will be sent to a special lab for analysis and diagnosis of endometriosis by an innovative proprietary procedure that analyses the cells of the tissue collected in the biopsy. The results of the biopsy will be compared to the laparoscopy for accuracy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
75
Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record
Valley OB-GYN Clinic, PC
Saginaw, Michigan, United States
NOT_YET_RECRUITINGCorpus Christi Women's Center
Corpus Christi, Texas, United States
RECRUITINGUniversity of Texas Physician's Women's Center--Memorial City
Houston, Texas, United States
RECRUITINGPrimary Outcome
Endometriosis diagnosis
Time frame: 1 week after laparoscopy
Secondary Outcome
Accurate staging of endometriosis
Time frame: 1 week after laparoscopy
Tertiary Outcome
observe and explore any relationship between subject's estrogen and progesterone levels and MetriDx results.
Time frame: 1 week after providing menstrual effluent sample
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