The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA

Last updated: August 29, 2024
Sponsor: Dot Laboratories, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

N/A

Clinical Study ID

NCT04598698
Dot Laboratories DL-001
  • Ages 18-49
  • Female

Study Summary

Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant is willing and able to provide written informed consent.

  2. Participant is willing and able to provide up to 50 mL of blood via venipuncture andcomply with all other study and sample collection procedures.

  3. Participant is a female aged 18 through 49 years (inclusive).

  4. Participant is scheduled to undergo:

  5. Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis.This shall constitute approximately 95% of the participants enrolled.

  6. Laparotomy, laparoscopy, or other procedures including, but not limited to,tubal ligation, lysis of adhesions, hysterectomy for benign condition,myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy forindications including, but not limited to, infertility or benign gynecologicalindications (e.g., benign pelvic masses, infertility, abnormal uterinebleeding). This shall constitute approximately 5% of the participants enrolled.

Exclusion

Exclusion Criteria:

  1. Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).

  2. Participant is a female in a pre-menarchal or post-menopausal state (last menstrualperiod at least 1 year before Screening and no other biological or physiologicalcause can be identified) or has been rendered surgically menopausal (bilateraloophorectomy) for at least 6 months at Screening.

  3. Participant is pregnant.

  4. Participant has an active malignancy.

  5. Participant is known to have tested positive for human immunodeficiency virus orhepatitis A, B, or C.

  6. Participant has an active pelvic infection or other infections contraindicated forsurgery.

  7. Participant has participated (±3 months of study enrollment) in a clinical trialwhere an investigational drug was or is planned to be administered.

  8. Participant has any general health or behavioral condition that, in the opinion ofthe investigator, should exclude the participant from participation.

Study Design

Total Participants: 750
Study Start date:
November 02, 2020
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Stanford University Hospital

    Palo Alto, California 94031
    United States

    Site Not Available

  • Center for Special Minimally Invasive & Robotic Surgery

    Woodside, California 94061
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Christiana Care

    Newark, Delaware 19713
    United States

    Site Not Available

  • RAD Fertility

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Academia of Women's Health and Endoscopic Surgery

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Evanston, Illinois 60201
    United States

    Site Not Available

  • The Advanced Gynecologic Surgery Institute

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • University of Louisville Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Rutgers Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • NewYork-Presbyterian / Columbia University Medical Center

    New York, New York 10019
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Penn State Health

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UT Austin

    Austin, Texas 78712
    United States

    Site Not Available

  • Seattle Reproductive Medicine

    Seattle, Washington 98109
    United States

    Site Not Available

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