Tests a uterine tissue biopsy test to help diagnose endometriosis
Tests a uterine tissue biopsy test to diagnose endometriosis without surgery in adults.
Plain-language title generated from the registry record
Registry title: Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
Key facts
- Where
- Corpus Christi, Houston, and Saginaw, United StatesSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT05698212, who can take part
Where in United States
- Corpus Christi Women's CenterCorpus Christi, United StatesTaking people
- University of Texas Physician's Women's Center--Memorial CityHouston, United StatesTaking people
- Valley OB-GYN Clinic, PCSaginaw, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hera Biotech, Inc.
- Trial code
- NCT05698212
- Record updated
- 26 January 2023
- Original description
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.Read full original descriptionShow less
Proof-of-Concept, Obs Study to Evaluate Accuracy of MetriDx Lab Developed Test (LDT) to Accurately Identify Endometriosis-specific Biological Markers Using Micro-fluidic Analysis of Cells Enabling Clinicians to Diagnose Endometriosis
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: 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 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. Subjects will be assigned to Cohort 3.
Exclusion: 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; Is currently taking a blood thinner medication; Undergoing fertility or hormone therapy treatments; Has participated in any interventional clinical trial in the previous 90 days in which an investigational drug was administered; Surgical history of hysterectomy; 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; 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 a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years; Younger than 18 or 51 years or older; Has a BMI 40 or above; Currently, pregnant, breast feeding, or has given birth in the last 6 months; History or evidence of uterine fibroids.