Endometrial cryoablation with ultrasound visualization in women undergoing hysterectomy.
OBJECTIVE
To evaluate tissue effects of cryosurgical endometrial ablation in women just before hysterectomy, characterize ultrasound monitoring of freezing, determine the feasibility of a new probe-angling procedure, and assess the safety profile by monitoring serosal surface temperatures.


METHODS
Single arm safety study enrolling ten women at two centers (Canadian Task Force classification II-2).


METHODS
Two clinical sites. Patients. Ten women scheduled for hysterectomy.


METHODS
Hysterectomy with a new cryosurgical device (First Option, CryoGen, Inc., San Diego, CA) that achieves surface temperatures below -90 inverted exclamation mark C to freeze endometrium.


RESULTS
The freeze protocol involved angling the probe toward each cornu. Maximum ice front diameter at the end of the first angled freeze ranged from 24 to 34 mm, and maximum ice ball diameter at the end of the second freeze ranged from 28 to 37 mm. The margin between the advancing ice front and serosal surface was monitored by ultrasound. In all cases the margin was safe and no reduction in serosal surface temperatures occurred. Depth of necrosis ranged from 9 to 12 mm as determined by tetrazolium staining and electron microscopy, and there was no full-thickness myometrial destruction. Total endometrial destruction was achieved.


CONCLUSIONS
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.
Dobak
J D
JD
CryoGen Inc., San Diego, California, USA.
Willems
J
J
Howard
R
R
Shea
C
C
Townsend
D E
DE
D000328:Adult; D004396:Coloring Agents; D003452:Cryosurgery / Q000295:instrumentation / Q000379:methods; D004717:Endometrium / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D014463:Ultrasonography / Q000379:methods
D004396:Coloring Agents