Research & Development
AEGEA Medical Completes Enrollment in the Pace II Clinical Trial
9 January 2019 - - US-based medical technology company AEGEA Medical has completed enrollment in the Post-Ablation Cavity Evaluation (PACE II) clinical study in women who previously underwent endometrial ablation as part of a pivotal trial of AEGEA's Adaptive Vapor Ablation technology, the company said.

The multi-centre observational study enrolled 50 women at seven sites across the US.

The trial was designed to assess uterine cavity access as well as the projected feasibility of diagnostic and therapeutic interventions three to four years following treatment.

PACE II enrollment commenced in the fall of 2018, with data to be released throughout 2019.

The study's National Principal Investigator is Alan Johns, MD, Medical director, Baylor Research Institute, Fort Worth.

Endometrial ablation is a safe, effective and fast-growing procedure for the treatment of heavy menstrual bleeding (menorrhagia), with the number of US cases estimated to have increased from 430,000 in 2014 to 490,000 in 2017 alone.

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.

In these scenarios, the lack of post-procedure uterine cavity access often leaves women with hysterectomy as the only viable option.

Many women experience heavy menstrual bleeding at some point in their lives.

Nearly 1 in 5 women between the ages of 30 and 50 experience abnormally heavy or prolonged menstrual bleeding. Healthcare professionals call this condition "abnormal uterine bleeding " or "menorrhagia." The increase in quantity and duration can negatively impact every day routine activities such as work and family care.

It can also make it difficult to exercise and to be socially or sexually active.

The AEGEA Vapor System is indicated for premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.

AEGEA Medical is developing the application of its Adaptive Vapor Ablation technology to deliver therapies that provide high quality patient outcomes to a wider range of patients. AEGEA's FDA approved water vapor technology enables the delivery of a safe and effective endometrial ablation for the treatment of menorrhagia in a simple, office-based procedure that takes only minutes.

With a vision to expand safe and effective treatment options to more patients, and provide physicians with the confidence and convenience necessary to perform office-based procedures, AEGEA is inspiring new approaches to women's healthcare.

Founded in 2008, AEGEA Medical is located in Menlo Park, Calif.