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EMPOWER: Endometriosis Diagnosis Using MicroRNA: PrOspective study in Women to Allow Early Disease Recognition (EMPOWER)
Rochester, Minn.
The purpose of this study is to evaluate a non-invasive diagnostic test (DotEndo) for endometriosis. Dot Laboratories, Inc. (DotLab) has identified a panel of circulating microRNAs (miRNAs) that are significantly and differentially expressed between patients with endometriosis compared with control patients with other benign gynecological diseases.
Endometriosis is a debilitating, chronic inflammatory condition that affects over 5 million women in the United States and approximately 10% of women of reproductive age worldwide. Standard clinical practice for diagnosing endometriosis is through laparoscopy using visual examination. Laparoscopy is an invasive, costly procedure that must be performed by specialists, and carries risks associated with surgery.
DotEndo is a non-invasive in vitro diagnostic test that measures levels of circulating miRNA biomarkers in whole blood. The DotEndo blood test will use a distinct classifier algorithm, based on levels of disease-specific miRNAs, to aid in the diagnosis of active endometriosis disease.
Closed for Enrollment
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A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing Efficacy, Safety, Dose-response of Quinagolide Vaginal Rings Administered Sequentially for 4 Menstrual Cycles in Women With Moderate-Severe Endometriosis-related Pain (RAQUEL)
Rochester, Minn.
The purpose of this study is to evaluate the effectiveness of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate-to-severe endometriosis-related pain
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Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
Rochester, Minn.
The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use.
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An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients with Endometriosis (OPINE) (OPINE)
Rochester, Minn.,
Scottsdale/Phoenix, Ariz.
The purpose of this study is to explore Biovitals™ wearable device and mobile platform’s ability to detect and quantify various levels of endometriosis pain when used in a home-use setting.
A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood.
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