Department of Gynecology, Universidad Autónoma de Nuevo León Facultad de Medicina, Monterrey, Nuevo León, Mexico.
J Minim Invasive Gynecol. 2011 Jul-Aug;18(4):445-8. doi: 10.1016/j.jmig.2011.03.008.
To evaluate the AEGEA vapor-based endometrial ablation system using an in vivo peri-hysterectomy model.
Single-site feasibility study (Canadian Task Force classification II-2).
University medical center.
Nine women consented to undergo AEGEA endometrial ablation before previously scheduled abdominal hysterectomy to treat abnormal uterine bleeding.
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).
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.
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.
使用体内子宫切除术模型评估 AEGEA 蒸汽子宫内膜消融系统。
单站点可行性研究（加拿大任务组分类 II-2）。
大学医疗中心。
9 名女性同意在计划进行腹部子宫切除术之前接受 AEGEA 子宫内膜消融术，以治疗异常子宫出血。
在体内使用 90 秒蒸汽处理周期进行 AEGEA 子宫内膜消融。子宫切除术后，通过宏观三苯基四唑氯（TTC）染色检查子宫内膜消融的范围和位置，通过微观硝基四唑蓝（NBT）染色检查输卵管损伤。
9 个子宫的平均（标准差）治疗后测量值如下：重量 143（40）g；长度 10.3（1.3）cm；厚度 4.4（0.6）cm；宽度 6.2（0.7）cm。子宫内膜厚度为 1.1（0.7）mm。3 个子宫有小于 2cm 的肌瘤；2 个子宫有局灶性子宫腺肌病。未发现子宫肌层穿孔或热浆膜损伤。中位子宫体、子宫下段腔和双侧宫角 TTC 阴性表面子宫内膜处理的百分比分别为 100%（范围：100-100%）、100%（范围：80-100%）和 100%（范围：95-100%）。消融与浆膜之间的最短距离为 11.5（3.2）mm。未发现宫颈下段或宫颈外的热损伤。评估的间质段中 18%有最小的输卵管热损伤，最大深度为 0.6 至 0.8mm，延伸至浆膜 6.3 至 9.5mm 以内。在子宫外输卵管段未发现热损伤。
AEGEA 蒸汽子宫内膜消融系统具有提供全层子宫内膜消融的良好宫腔覆盖的潜力。研究结果进一步支持未来临床疗效试验具有可接受的体内安全性特征。
