NCT05698212 Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers
| NCT ID | NCT05698212 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hera Biotech, Inc. |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2022-09-14 |
| Primary Completion | 2023-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2022-09-14 with a primary completion date of 2023-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 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 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.
Contact & Investigator
Sandra M Hurtado, MD
PRINCIPAL INVESTIGATOR
University of Texas Physicians Women's Center
Frequently Asked Questions
Who can join the NCT05698212 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05698212 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05698212 currently recruiting?
Yes, NCT05698212 is actively recruiting participants. Contact the research team at janan@tammnet.com for enrollment information.
Where is the NCT05698212 trial being conducted?
This trial is being conducted at Saginaw, United States, Corpus Christi, United States, Houston, United States.
Who is sponsoring the NCT05698212 clinical trial?
NCT05698212 is sponsored by Hera Biotech, Inc.. The principal investigator is Sandra M Hurtado, MD at University of Texas Physicians Women's Center. The trial plans to enroll 75 participants.