ClinicalTrials.gg
Status unknownNCT04598698EMPOWERUpdated Aug 30, 2024

The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA

An observational study in Endometriosis, sponsored by Dot Laboratories, Inc.. Status unknown at 23 sites in United States. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-08-30.

Sponsored by Dot Laboratories, Inc. · Observational

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years to 49 Years
Sex
Female
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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.

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Conditions studied

  • Endometriosis

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In context

Endometriosis

925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.

This study's planned enrollment of 750 is above the median of 125 across 354 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

This is the only study on the registry with Dot Laboratories, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women of reproductive age who have been referred to surgery for suspected endometriosis and other benign gynecological indications.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and comply 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:

    1. Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis. This shall constitute approximately 95% of the participants enrolled.
    2. 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 for indications including, but not limited to, infertility or benign gynecological indications (e.g., benign pelvic masses, infertility, abnormal uterine bleeding). This shall constitute approximately 5% of the participants enrolled.

Exclusion criteria

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 menstrual period at least 1 year before Screening and no other biological or physiological cause can be identified) or has been rendered surgically menopausal (bilateral oophorectomy) 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 or hepatitis A, B, or C.
  6. Participant has an active pelvic infection or other infections contraindicated for surgery.
  7. Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
  8. Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Clinical validity

    Performance of a microRNA (miRNA)-based assay compared to visual inspection during surgery for the diagnosis of active endometriosis

    Time frame: From date of first sample collection to surgery, up to 3 weeks

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Study locations

23 sites
  • Stanford University Hospital
    Palo Alto, California 94031, United States
  • Center for Special Minimally Invasive & Robotic Surgery
    Woodside, California 94061, United States
  • Yale University
    New Haven, Connecticut 06510, United States
  • Christiana Care
    Newark, Delaware 19713, United States
  • RAD Fertility
    Newark, Delaware 19713, United States
  • MedStar Washington Hospital Center
    Washington D.C., District of Columbia 20010, United States
  • University of South Florida
    Tampa, Florida 33606, United States
  • Academia of Women's Health and Endoscopic Surgery
    Atlanta, Georgia 30328, United States
  • Northwestern Medicine
    Chicago, Illinois 60611, United States
  • NorthShore University HealthSystem
    Evanston, Illinois 60201, United States
  • The Advanced Gynecologic Surgery Institute
    Park Ridge, Illinois 60068, United States
  • University of Louisville Hospital
    Louisville, Kentucky 40202, United States
  • Johns Hopkins University
    Baltimore, Maryland 21205, United States
  • Rutgers Robert Wood Johnson University Hospital
    New Brunswick, New Jersey 08901, United States
  • NewYork-Presbyterian / Columbia University Medical Center
    New York, New York 10019, United States
  • University Hospitals
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • Penn State Health
    Hershey, Pennsylvania 17033, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • UT Austin
    Austin, Texas 78712, United States
  • Seattle Reproductive Medicine
    Seattle, Washington 98109, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04598698
Lead sponsor
Dot Laboratories, Inc.
Responsible party
Sponsor
First posted
Oct 22, 2020
Start date
Nov 2, 2020
Primary completion
May 3, 2023
Completion
Dec 2024 (estimated)
Last update
Aug 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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