The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA
NCT ID: NCT04598698
Last Updated: 2024-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
750 participants
OBSERVATIONAL
2020-11-02
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
49 Years
FEMALE
No
Sponsors
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Dot Laboratories, Inc.
INDUSTRY
Responsible Party
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Locations
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Stanford University Hospital
Palo Alto, California, United States
Center for Special Minimally Invasive & Robotic Surgery
Woodside, California, United States
Yale University
New Haven, Connecticut, United States
Christiana Care
Newark, Delaware, United States
RAD Fertility
Newark, Delaware, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
Academia of Women's Health and Endoscopic Surgery
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
The Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Johns Hopkins University
Baltimore, Maryland, United States
Rutgers Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
NewYork-Presbyterian / Columbia University Medical Center
New York, New York, United States
University Hospitals
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Penn State Health
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UT Austin
Austin, Texas, United States
Seattle Reproductive Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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Dot Laboratories DL-001
Identifier Type: -
Identifier Source: org_study_id
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