The EMPOWER Study: Endometriosis Diagnosis Using microRNA (EMPOWER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04598698|
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : January 12, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||750 participants|
|Official Title:||Endometriosis Diagnosis Using microRNA: Prospective Study in Women to Allow Early Disease Recognition|
|Actual Study Start Date :||November 2, 2020|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2024|
- Clinical validity [ Time Frame: From date of first sample collection to surgery, up to 3 weeks ]Performance of a microRNA (miRNA)-based assay compared to visual inspection during surgery for the diagnosis of active endometriosis
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 49 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Participant is willing and able to provide written informed consent.
- 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.
- Participant is a female aged 18 through 49 years (inclusive).
Participant is scheduled to undergo:
- Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis. This shall constitute approximately 95% of the participants enrolled.
- 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.
- Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
- 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.
- Participant is pregnant.
- Participant has an active malignancy.
- Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
- Participant has an active pelvic infection or other infections contraindicated for surgery.
- Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
- Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04598698
|Contact: Melissa Stosicemail@example.com|
|Responsible Party:||Dot Laboratories, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 22, 2020 Key Record Dates|
|Last Update Posted:||January 12, 2022|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications