Abstract
BackgroundUterine 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.MethodsElectromagnetic 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.ResultsThe 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.ConclusionsThe 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.
Highlights
Uterine fibroids occur singly or as multiple benign tumors originating in the myometrium
Lack of real-time imaging is especially problematic for the surgeon if the patient has symptomatic intramural fibroids or intramural fibroids abutting—but not distorting—the endometrium (IMAEs)
Female premenopausal subjects ≥18 years of age and with symptomatic uterine fibroids diagnosed on transvaginal ultrasound were recruited from one private gynecology office located in the San Francisco Bay Area
Summary
This ongoing study is a post-market prospective evaluation of the Acessa System with targeting animation guidance (TAG) [ClinicalTrials.gov Identifier: NCT01842789] (Figs. 1, 2). A very small wire coil (sensor) is incorporated both in the tip of the Acessa handpiece and at the distal end of a sheath placed over the LUS transducer. The software uses the characteristics of the induced voltage from each sensor to create virtual representations of the LUS transducer and the handpiece in relation to their spatial relationship. These avatars are displayed on an external monitor and show the physician the future path of the handpiece in relation to the displayed LUS image of the target fibroid. The local Institutional Review Board approved the study, and all participants signed informed consent
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