Aegea Medical launches post-market Adaptive Vapor Ablation study

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...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Women's Health aegeamedical Source Type: news