Uterine Myoma Clinical Trial
Official title:
Tissue Effect in Extirpated Uterine Fibroid Tissue Using Existing Olympus Radiofrequency Probes for Fibroids Ablation (Radio Frequency Ablation RFA STUDY )
The aim of this study is to investigate the safety and feasibility of a radiofrequency (RF) system employing RFITT (CelonProSurge) probes for the ablative treatment of uterine fibroids.
10 consecutive premenopausal women with symptomatic uterine fibroids not responsive to
medical therapies (including progestins, oral contraceptives, and anti-inflammatory drugs)
will be recruited at our hospital to be submitted to abdominal myomectomy. All patients will
be counseled on the potential risks and benefits of the procedure before giving their own
written consent.
Procedures will be performed at the hospital and patients will be under general
anesthesia.All patients will be submitted to abdominal myomectomy. Target leiomyomas will be
intramural, 5-15 cm in diameter. Intra-operative RF ablation will be carried out followed by
surgical removal of the treated leiomyoma. After the removing of the fibroid, it will be
send to the pathologist. Specimens of fibroid will be fixed immediately in 10% neutral
formaline solution for approximately 3h, then embedded in paraffin, cut into 4mm section and
stained with along the direction of the RFA electrode. Pathologic confirmation of ablation
will be assessed as follows: the specimens of leiomyoma will be examined grossly for the
histologic leiomyoma subtype and for pathologic findings representing treatment, including
necrosis, hemorrhage, or fibrosis, using hematoxylin and eosin staining. Treated areas will
be measured for their largest orthogonal dimensions in the planar cut surface with the third
dimension estimated by summing the affected 0.5-cm-thick sagittal planes. RF ablation
volumes will be calculated using the prolate ellipsoid formula. The relationship between
thermal dose estimates and pathology will be assessed using Bland-Altman analyses and
intra-class correlations. The surgical procedure will be concluded as usual with the same
steps of standard approach.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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