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New treatment option for Endometriosis
Official title Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
ClinicalTrials.gov ID: NCT05698212
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- Surgical report from prior laparoscopy must indicate that endometriosis was not treated with surgical ablation or excision.
- people will be assigned to Cohort 1 or 2 based on diagnosis and staging results from laparoscopy.
- Or for Cohort 3:
- Not suspected of having endometriosis
- no 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. people will be assigned to Cohort 3.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Saginaw, Michigan, United States
- Corpus Christi, Texas, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saginaw, Michigan, United States; Corpus Christi, Texas, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.