Electromagnetic image guidance in gynecology: prospective study of a new laparoscopic imaging and targeting technique for the treatment of symptomatic uterine fibroids

Abstract

Background: Uterine fibroids occur singly or as multiple benign tumors originating in the myometrium. Because they vary in size and location, the approach and technique for their identification and surgical management vary. Reference images, such as ultrasound images, magnetic resonance images, and sonohystograms, do not provide real-time intraoperative findings.

Methods: Electromagnetic image guidance, as incorporated in the Acessa Guidance System, has been cleared by the FDA to facilitate targeting and ablation of uterine fibroids during laparoscopic surgery. This is the first feasibility study to verify the features and usefulness of the guidance system in targeting symptomatic uterine fibroids-particularly hard-to-reach intramural fibroids and those abutting the endometrium. One gynecologic surgeon, who had extensive prior experience in laparoscopic ultrasound-guided identification of fibroids, treated five women with symptomatic uterine fibroids using the Acessa Guidance System. The surgeon evaluated the system and its features in terms of responses to prescribed statements; the responses were analyzed prospectively.

Results: The surgeon strongly agreed (96 %) or agreed (4 %) with statements describing the helpfulness of the transducer and handpiece's dynamic animation in targeting each fibroid, reaching the fibroid quickly, visualizing the positions of the transducer and handpiece within the pelvic cavity, and providing the surgeon with confidence when targeting the fibroid even during "out-of-plane" positioning of the handpiece.

Conclusions: The surgeon's positive user experience was evident in the guidance system's facilitation of accurate handpiece tip placement during targeting and ablation of uterine fibroids. Continued study of electromagnetic image guidance in the laparoscopic identification and treatment of fibroids is warranted. ClinicalTrials.gov Identifier: NCT01842789.

Figures

Fig. 1

Surgeon’s view of real-time operative screens (from left-to-right): laparoscopic view of radiofrequency ablation handpiece inserted into a large intramural fibroid, Acessa Guidance screens, and Acessa System screen prior to deployment of electrode array

Fig. 2

Acessa Guidance screens. (Left) Laparoscopic ultrasound view of Acessa handpiece tip entering fibroid from left to right within the two (purple) virtual tracking lines of the target zone; (right) computer-generated view of the relationship of the ultrasound beam and trajectory of the handpiece tip into uterus and fibroid