NCT05698212

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

January 26, 2023

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

November 29, 2022

Last Update Submit

January 24, 2023

Conditions

EndometriosisDiagnosis

Keywords

endometriosisMetriDxconnexinsbiological markersmicro-fluidic analysisuterine tissue biopsy

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    Endometriosis diagnosis

    1 week after laparoscopy

Secondary Outcomes (2)

  • Secondary Outcome

    1 week after laparoscopy

  • Tertiary Outcome

    1 week after providing menstrual effluent sample

Study Arms (3)

Cohort 1

ACTIVE COMPARATOR

Endometriosis diagnosed at stage 1 or 2

Diagnostic Test: MetriDx

Cohort 2

ACTIVE COMPARATOR

Endometriosis diagnosed at stage 3 or 4

Diagnostic Test: MetriDx

Cohort 3

OTHER

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

Diagnostic Test: MetriDx

Interventions

MetriDxDIAGNOSTIC_TEST

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNatural born female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify 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 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).
  • +1 more criteria

You may not qualify 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 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Valley OB-GYN Clinic, PC

Saginaw, Michigan, 48602, United States

NOT YET RECRUITING

Corpus Christi Women's Center

Corpus Christi, Texas, 78412, United States

RECRUITING

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

Houston, Texas, 77024, United States

RECRUITING

MeSH Terms

Conditions

EndometriosisDisease

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sandra M Hurtado, MD

    University of Texas Physicians Women's Center

    PRINCIPAL INVESTIGATOR

  • Charles R Kirkham, MD

    Corpus Christi Women's Clinic

    PRINCIPAL INVESTIGATOR

  • Jacqueline A Robinson, MD

    Valley OB-GYN Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Janan Van Osdell, MHSA

CONTACT

855-826-6638janan@tammnet.com

Somer Baburek, MBA

CONTACT

210-683-1069somer@herabiotech.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The lab associates conducting the diagnosis tests are blinded.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Two cohorts defined by confirmed diagnosis of endometriosis and further grouping by staging of endometriosis A third cohort of control participants who have not been suspected or diagnosed with endometriosis
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

January 26, 2023

Study Start

September 14, 2022

Primary Completion

March 25, 2023

Study Completion

April 10, 2023

Last Updated

January 26, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)