Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers

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.

Inclusion Criteria:Able to understand and provide informed consent.Natural born female of childbearing potential.Age between 18 and 50, inclusive.Not pregnant at Visit 0 (screening) or Visit 1 (day of procedure).Free of systemic or pelvic disorder that, in the opinion of the investigator, may interfere with the tissue collection procedure, analysis of the tissue or increase the risk to subject.Must not have received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.For Cohort 1 and 2:Suspected of having endometriosis, or previously diagnosed with endometriosis, and currently recommended for laparoscopic surgery by physician.Must have laparoscopic surgery within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day), or a laparoscopy on record within the 12 months prior to Visit 0 for diagnosis only.Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.Subjects will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.Or for Cohort 3:Not suspected of having endometriosisno previous diagnosis or symptoms of endometriosis, who have had a laparoscopy for another reason, such as tubal ligation or other abdominal procedure, within the past 12 months prior to screening Visit 0,or laparoscopy to be completed within 60 days after screening Visit 0 and any time after the endometrial biopsy is obtained on Visit 1 (including the same day).Surgeon's report must have no supplemental observations of endometriosis lesions or diagnosis. Subjects will be assigned to Cohort 3.Exclusion Criteria:Younger than 18 or 51 years or older.Surgical history of hysterectomy.Has received excision or ablation surgical procedure or treatment, such as gonadotropin-releasing hormone (GnRH), for endometriosis within the past 12 months.Cohort 3: Prior diagnosis of endometriosis, or surgical note from prior laparoscopy that indicates endometriosis lesions were observed.Has a BMI 40 or above.Is currently taking a blood thinner medication.Currently, pregnant, breast feeding, or has given birth in the last 6 months.Diagnosed with HIV, AIDS, hepatitis A, B, or C, or has active malignancy.Has a complicating condition that would pose a hazard to tissue handling.Undergoing fertility or hormone therapy treatments.History or evidence of uterine fibroids.History of reproductive cancer.Has a condition that, in the opinion of the investigator, would confound tissue collection or analysis.Has an active pelvic infection or other infections contra-indicated for laparoscopy.Has participated in any interventional clinical trial in the previous 90 days in which an investigational drug was administered.Has a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years.