LIVERMORE, Calif., Nov. 12, 2013 /PRNewswire/ -- Halt Medical today announced that data from a large multi-center clinical study of the Acessa™ Procedure showed that women with uterine fibroids experienced significant and long-term improvement in their symptoms and for 95 percent of women, use of this procedure did not require further fibroid treatment during the two-year study follow-up. Results from The Halt Fibroid Study were presented today at the 42nd AAGL Global Congress on Minimally Invasive Gynecology near Washington, D.C. The AAGL is the world's premiere professional society dedicated to minimally invasive surgery in gynecology.
According to the National Institutes of Health, uterine fibroids are a common condition affecting at least 70 percent of all women by age 50. The size of fibroids can vary greatly, ranging from microscopic to the size of a melon. And symptoms may vary widely from prolonged and heavy menstrual blood flow and bloating to pelvic pain, cramping, and anemia. While fibroids are nearly always noncancerous, they are most often treated by the complete removal of the uterus in a hysterectomy procedure.
The population under study included 135 women with ≤ 6 treatable fibroids and heavy menstrual bleeding who were treated with the Acessa Procedure and followed for 24 months. Patients participating in the study quickly experienced significant improvement in their symptom severity; these results were sustained over two years with the symptom severity scores decreasing significantly compared to the pretreatment scores. The overall incidence of adverse events and retreatment rates were low.
Women with fibroids often are self-conscious, concerned about their health and lack the energy to participate in physical or social activities. The Halt Fibroid Study also found that many women treated with Acessa experienced substantial improvements in how they felt about their condition and themselves as early as three months following the procedure, with results maintained for two years. Importantly, health-related quality of life (HRQL) scores increased significantly by 41 percent when compared to the baseline measurement. Additionally, HRQL sub-scores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function).