Aegea Medical said today that it launched a new post-market study exploring the long-term effects of its Adaptive Vapor Ablation technology in endometrial ablation procedures.
The PACE II study will look to enroll up to 50 women who were previously treated in the Menlo Park, Calif.-based company’s pivotal trial of the Adaptive Vapor Ablation tech and will analyze uterine cavity access and the feasibility of diagnostic and therapeutic interventions for three to four years post-treatment.
“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. 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,” prez & CEO Maria Sainz said in a press release.
In the pivotal PACE study, investigators found that post-procedure access to the mid-uterine cavity or beyond was possible in 82% of the 11 patients who had participated in an earlier Phase II study.
The observational endpoint of the trial includes endometrial biopsy and IUD placement, the ability to visualize the uterine cornia and ostia and the presence and characteristics of adhesions within the uterine cavity, Aegea said. The company is hopeful it will complete the trial within six months.
“Post-procedure uterine cavity access is the next big topic in endometrial ablation. 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,” study national principal investigator Dr. Alan Johns of Fort Worth, Texas’s Clinical Research Baylor Research Institute said in a prepared statement.
In May, Aegea Medical said that it tapped former Cardiokinetix prez & CEO Maria Sainz as its new president and chief executive officer.