Successful Vapor-Based Endometrial Ablation: In Vivo Peri-Hysterectomy Study

Abstract Study Objective To evaluate the AEGEA vapor-based endometrial ablation system using an in vivo peri-hysterectomy model. Design Single-site feasibility study (Canadian Task Force classification II-2). Setting University medical center. Patients Nine women consented to undergo AEGEA endometrial ablation before previously scheduled abdominal hysterectomy to treat abnormal uterine bleeding. Interventions In vivo AEGEA endometrial ablation was performed using a 90-second vapor treatment cycle. After hysterectomy, the uteri were examined for the extent and location of endomyometrial ablation (macroscopic triphenyltetrazolium chloride staining) and fallopian tube injury (microscopic nitroblue tetrazolium staining). Measurements and Main Results The mean (SD) posttreatment measurements of the 9 uteri were as follows: weight, 143 (40) g; length, 10.3 (1.3 cm); thickness, 4.4 (0.6) cm; and width, 6.2 (0.7) cm. The endometrial thickness was 1.1 (0.7) mm. Three uteri had myomas that measured less than 2 cm; and 2 uteri demonstrated focal adenomyosis. No myometrial perforation or thermal serosal injury was identified. The median corpus, lower uterine cavity and bilateral cornua percentages of TTC-negative surface endometrial treatment were 100% (range: 100-100%), 100% (range: 80-100%), and 100% (range: 95-100%), respectively. The closest distance between the ablation and serosa was 11.5 (3.2) mm. No lower endocervical or exocervical thermal injury was identified. Minimal fallopian tube thermal injury was identified in 18% of interstitial segments evaluated, and measured 0.6 to 0.8 mm in maximal depth and extended to within 6.3 to 9.5 mm of the serosa. No thermal injury was identified in the extrauterine fallopian tube segments. Conclusion The AEGEA vapor-based endometrial ablation system has the potential to provide excellent cavity coverage with full-thickness endometrial ablation. The study results further support an acceptable in vivo safety profile for future clinical efficacy trials.