Endometrial cryoablation with ultrasound visualization in women undergoinghysterectomy

Study Objectives. To evaluate tissue effects of cryosurgical endometrial ab lation in women just before hysterectomy, characterize ultrasound monitorin g of freezing, determine the feasibility of a new probe-angling procedure, and assess the safety profile by monitoring serosal surface temperatures. Design. Single arm safety study enrolling ten women at two centers (Canadia n Task Force classification II-2). Setting. Two clinical sites. Patients. Ten women scheduled for hysterectomy. Intervention. Hysterectomy with a new cryosurgical device (First Option, CryoGen, Inc., San Diego, CA) that achieves surface temperatures below -90 degrees C to freeze endometri um. Measurements and Main Results. The freeze protocol involved angling the pro be toward each cornu. Maximum ice front diameter at the end of the first an gled freeze ranged from 24 to 34 mm, and maximum ice ball diameter at the e nd of the second freeze ranged from 28 to 37 mm. The margin between the adv ancing ice front and serosal surface was monitored by ultrasound. In all ca ses the margin was safe and no reduction in serosal surface temperatures oc curred. Depth of necrosis ranged from 9 to 12 mm as determined by tetrazoli um staining and electron microscopy, and there was no hull-thickness myomet rial destruction. Total endometrial destruction was achieved. Conclusion. Cryosurgical ablation of the endometrium with the First Option system with angled freezes and ultrasound monitoring appears to be feasible and safe given our preliminary data.