AEGEA Medical announced that it has completed enrollment in the Post-Ablation Cavity Evaluation Mexico (PACE MX) clinical study of women who previously underwent endometrial ablation as part of a pivotal trial of AEGEA’s Mara Water Vapor Ablation Treatment.
Image: A stethoscope, which used by doctors. Photo: Courtesy of Hush Naidoo on Unsplash.
The PACE MX study is the third study of its kind, following the PACE Pilot and PACE II studies. As in the previous PACE studies, PACE MX assesses uterine cavity access as well as the projected feasibility of minimally invasive diagnostic and therapeutic interventions more than four years following uterine ablation treatment for heavy menstrual bleeding.
Furthermore, the PACE studies will evaluate the potential correlation, if any, between ease of long- term access to the uterine cavity and menstrual bleeding status after the water vapor ablation procedure. The observational study enrolled 22 women at the Hospital Universitario “Dr. José Eleuterio González“ de la Universidad Autónoma De Nuevo León(UANL) in Monterrey, Mexico, one of the AEGEA Water Vapor Ablation pivotal trial sites.
“Ease of long-term hysteroscopic uterine cavity access after endometrial ablation is critical to a woman’s ongoing clinical care. The PACE studies, including PACE MX, will provide important evidence to help us better understand the longer-term implications of water vapor ablation and the potential to preserve minimally invasive diagnostic and treatment options,”said PACE MX study principal investigator Dr. JoséGerardo Garza Leal of UANL.
Endometrial ablation is a safe, effective and fast-growing procedure for the treatment of heavy menstrual bleeding (menorrhagia), with the number of U.S. cases estimated to have increased from 430,000 in 2014 to 490,000 in 2017 alone.1 As the number of procedures continues to rise per year, studies have shown that scar tissue and re-access to the cavity can be challenging post therapy, limiting the ability to search for suspected cancer via biopsy, and ruling out the use of IUDs for therapeutic intervention.2,3,4,5 In these scenarios, the lack of post-procedure uterine cavity access often leaves women with hysterectomy as the only viable option.
“AEGEA thanks Dr. Garza for leading this additional PACE MX study. Our efforts to further evaluate long-term uterine cavity access post ablation with the PACE studies are a vital addition to the growing body of evidence supporting the safety and efficacy profile of our innovative and natural Mara Water Vapor Ablation Treatment,” said Maria Sainz, president and CEO of AEGEA Medical. “The PACE studies will provide women and their physicians helpful data to assess the short-term and long-term benefits and implications of water vapor ablation for heavy menstrual bleeding.”
AEGEA’s Mara Water Vapor Ablation Treatment is the first FDA-approved endometrial ablation procedure for heavy menstrual bleeding that is specifically designed for use in the doctor’s office without general anesthesia. Mara is an innovative solution for endometrial ablation that uses water vapor to treat menorrhagia.The naturally expansive power of water vapor ensures a safe, effective and quick treatment thatcan be performed on patients with a wider range of uterine anatomies than alternative endometrial ablation treatment options. One year after treatment in the Pivotal Trial, 79 percent of patients reported normal menstrual bleeding or no menstrual bleeding at all7, 91 percent of patients were very satisfied or satisfied with the procedure, and 93 percent said they would recommend it to a friend.
The Post Ablation Cavity Evaluation observational clinical trials were designed to assess uterine cavity access and feasibility of future interventions three to four years post-ablation with the Mara Water Vapor Ablation System. The AEGEA PACE pilot study found that post-procedure access to the mid-uterine cavity or beyond was possible in 82 percent of the study’s 11 patients who previously participated in a Phase II study of water vapor ablation in The Netherlands. Based on these results, the Company launched and has completed enrollment in the PACE II and PACE MX studies. The PACE II study enrolled 50 women at seven sites across the U.S., with data to be released throughout 2019.
Many women experience heavy menstrual bleeding at some point in their lives. One in three women seek treatment for heavy menstrual bleeding.6Healthcare professionals call this condition “abnormal uterine bleeding (AUB)” or “menorrhagia”. The increase in quantity and duration of menstrual bleeding can negatively impact a woman’s physical, social and emotional well-being, and can make it difficult to engage in activities such as work, family care, exercise and sex.
The Mara Water Vapor Ablation System is indicated for premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. As with all surgical procedures, there are risks and considerations associated with the use of the Mara Water Vapor Ablation System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications.
Source: Company Press Release