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The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
The EASE Clinical Trial a prospective, multi-center, single-arm (open-label), non-randomized, clinical trial of the safety and effectiveness of endometrial ablation with the Minitouch System versus the FDA identified objective performance criteria (OPC) for global endometrial ablation (GEA) devices. The goal of the trial is to support reasonable safety and effectiveness of the investigational product compared to currently FDA-approved GEA devices.
Only eligible participants will undergo the Minitouch procedure. Post-treatment follow-up occurs approximately 24-hours post-procedure (via phone call) and in-person office visits occur 2-weeks, 3, 6 and 12-months post-procedure. Additional longer term follow-ups occur (via phone call or in-person office visits) 24 and 36-months post-procedure. The expected length of participation is approximately 37 months (inclusive of one month for screening and 36-months of post-procedure follow-up).
Not yet recruiting
Published on BioPortfolio: 2020-02-17T18:20:57-0500
A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life is...
The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.
The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of ...
As combat women soldiers are required to more intensive daily activity we believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iro...
The purpose of this systematic review is to identify the operative issues and specific dysmenorrhoea and menorrhagia outcomes in women who had fertility sparing surgery, as well as the expected oucome...
A recent review article on an aromatherapeutic inhaler demonstrated clinical effects on a number of bodily systems, like the cardiovascular system, the respiratory system, the nervous system and the e...
Cilia are ubiquitous in mammalian cells. The formation and assembly of cilia depend on the normal functioning of the ciliary transport system. In recent years, various proteins involved in the intrace...
The da Vinci Surgical System family remains the most widely used surgical robotic system for laparoscopy. Data about gastric bypass surgery with the Xi Surgical System are not available yet. We compar...
Megalin is a member of the low-density lipoprotein receptor superfamily. It has been recognized as an endocytic receptor for a large spectrum of ligands. As a consequence, megalin regulates homeostasi...
Excessive uterine bleeding during MENSTRUATION.
A group of enzymatic disorders affecting the nervous system and to a variable degree the skeletal system, lymphoreticular system, and other organs. The conditions are marked by an abnormal accumulation of catabolic material within lysosomes.
The system of glands that release their secretions (hormones) directly into the circulatory system. In addition to the ENDOCRINE GLANDS, included are the CHROMAFFIN SYSTEM and the NEUROSECRETORY SYSTEMS.
The biochemical and electrophysiological interactions between the NERVOUS SYSTEM and IMMUNE SYSTEM that result in regulation of the immune system by the nervous system.
Method for assessing flow through a system by injection of a known quantity of dye into the system and monitoring its concentration over time at a specific point in the system. (From Dorland, 28th ed)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...