AEGEA Medical, Inc. has announced the commencement of the Post-Ablation Cavity Access (PACE II) clinical study in women who previously underwent endometrial ablation as part of AEGEA’s pivotal trial of the company’s patented Adaptive Vapor Ablation technology. The multi-center observational study, which is being conducted at seven sites across the U.S. in up to 50 women, is designed to assess uterine cavity access as well as the feasibility of diagnostic and therapeutic interventions three to four years following treatment.
AEGEA Medical is conducting the PACE II study based on results from the AEGEA PACE pilot study, which 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 vapor ablation in The Netherlands. The primary observational endpoint of PACE II is the ability to access the uterine cavity and perform a diagnostic hysteroscopic exam, with other observational endpoints including feasibility of endometrial biopsy and IUD placement, the ability to visualize the uterine cornua/ostia, and presence and characteristics of adhesions within the uterine cavity. The company expects PACE II to be completed within six months.
“While endometrial ablation technologies have served physicians and their patients well for some time, the issue of post-procedure uterine cavity access has never really been addressed,” said Maria Sainz, president and CEO of AEGEA Medical. “We believe this is a very important success metric for the therapy, as it speaks to the possibility of future uterine-related interventions. The PACE Pilot data on 11 patients treated with Adaptive Vapor Ablation technology is very promising in how Vapor Ablation can address this unmet need, preserving physician and patient options in the future.”
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. 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 ultrasound or 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.
“Post-procedure uterine cavity access is the next big topic in endometrial ablation,” said the study’s National Principal Investigator, Alan Johns, MD, Medical Director, Clinical Research Baylor Research Institute, Fort Worth. “Given the early performance of AEGEA’s Adaptive Vapor Ablation technology in this area, I believe it has the potential to address this issue, providing physicians and patients with a more thoughtful approach to endometrial ablation that allows for future uterine interventions as necessary. Importantly, this multi-center study has been designed with objective criteria to avoid patient selection bias. Additionally, the study includes independent expert review of the hysteroscopy imagery to further increase the data’s scientific rigor.”