Recruiting

Phase 2

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

Sponsor:

Hera Biotech, Inc.

Code:

NCT05698212

Conditions

Endometriosis

Diagnosis

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

MetriDx

Study Details

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.

Conditions

Endometriosis

Diagnosis

Study ID

NCT05698212

Start date

Sep 14, 2022

Status verified date

Nov, 2022

Completion date

Apr 10, 2023

Anticipated

Primary completion date

Mar 25, 2023

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Cohort 1

Endometriosis diagnosed at stage 1 or 2

active comparator: Cohort 2

Endometriosis diagnosed at stage 3 or 4

other: Cohort 3

Control--Not suspected of having and absence of endometriosis confirmed by diagnostic test.

This group has uterine tissue biopsy and laparoscopy for non-endometriosis indication, i.e. tubal ligation

Interventions

MetriDx

Biopsied tissue will be analyze by proprietary LDT, MetriDx, and compared to laparoscopy diagnostic report on record

Primary outcome measure

Primary Outcome [ Time Frame: 1 week after laparoscopy ]

Central Contacts and Locations

Central contacts

Janan Van Osdell, MHSA

855-826-6638 janan@tammnet.com

Somer Baburek, MBA

210-683-1069 somer@herabiotech.com

Locations

Corpus Christi Women's Center

Recruiting

Corpus Christi, Texas, United States, 78412

Contacts

Jessica Sanchez

361-851-5000 Jessica.sanchez@elligodirect.com

Monica Marroquin

361-851-5000 monica.marroquin@elligodirect.com

Principal Investigator:

Charles R Kirkham, MD

University of Texas Physician's Women's Center--Memorial City

Recruiting

Houston, Texas, United States, 77024

Contacts

Lori L Wink, MSN, NP

706-251-8339 lori.L.wink@uth.tmc.edu

Principal Investigator:

Sandry Hurtago, MD

More Information

Sponsor

Hera Biotech, Inc.

Last update posted

Jan 26, 2023

Last verified

Nov, 2022

Keywords

endometriosis
MetriDx
connexins
biological markers
micro-fluidic analysis
uterine tissue biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hera Biotech, Inc. on 2023-01-26.