Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2014-12-31
2017-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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single arm
Intraoperative radiofrequency ablation
Intraoperative radiofrequency ablation
Intra-operative Radiofrequency ablation will be carried out and followed by surgical removal of the treated leiomyoma.
Interventions
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Intraoperative radiofrequency ablation
Intra-operative Radiofrequency ablation will be carried out and followed by surgical removal of the treated leiomyoma.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. presence of fibroid-related symptoms (menorrhagia, pelvic pain and/or bulk symptoms) not responsive to medical therapy;
3. uteri \<20-week gestational size on pelvic examination;
4. one myoma 5-15 cm in diameter as measured by transvaginal ultrasound;
5. desire for uterine preservation;
6. normal coagulation profile;
7. normal Pap test result in the last year,
8. hemoglobin level of 10.0 g/dL or more at the time of treatment.
Exclusion Criteria
2. a history of pelvic malignancy,
3. presence of cervical dysplasia,
4. a prior procedure to treat or remove myomas,
5. contraindications to general anesthesia or abdominal surgery.
25 Years
70 Years
FEMALE
No
Sponsors
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Olympus Winter & Ibe
UNKNOWN
Catholic University of the Sacred Heart
OTHER
Responsible Party
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Prof. Giovanni Scambia
Professor
Principal Investigators
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Giovanni Scambia, MD
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Sacred Heart - Rome
Locations
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Catholic University of Sacred Heart Rome,
Rome, Rome, Italy
Catholic University of Sacred Heart
Rome, Rome, Italy
Countries
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Central Contacts
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Facility Contacts
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Giovanni Scambia, Professor
Role: primary
Catholic University of Sacred Heart
Role: primary
References
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Bergamini V, Ghezzi F, Cromi A, Bellini G, Zanconato G, Scarperi S, Franchi M. Laparoscopic radiofrequency thermal ablation: a new approach to symptomatic uterine myomas. Am J Obstet Gynecol. 2005 Mar;192(3):768-73. doi: 10.1016/j.ajog.2004.10.591.
Mirza AN, Fornage BD, Sneige N, Kuerer HM, Newman LA, Ames FC, Singletary SE. Radiofrequency ablation of solid tumors. Cancer J. 2001 Mar-Apr;7(2):95-102.
Gazelle GS, Goldberg SN, Solbiati L, Livraghi T. Tumor ablation with radio-frequency energy. Radiology. 2000 Dec;217(3):633-46. doi: 10.1148/radiology.217.3.r00dc26633.
Kawamura K, Suzuki K, Tsugawa R, Taniguchi N, Matsunou H. Influence of RF capacitive heating on the alpha 1-adrenergic receptors of rat prostates. Eur Urol. 1994;25(4):330-3. doi: 10.1159/000475312.
Ichimura T, Kawamura N, Ito F, Shibata S, Minakuchi K, Tsujimura A, Umesaki N, Ogita S. Correlation between the growth of uterine leiomyomata and estrogen and progesterone receptor content in needle biopsy specimens. Fertil Steril. 1998 Nov;70(5):967-71. doi: 10.1016/s0015-0282(98)00300-8.
Other Identifiers
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4962/14
Identifier Type: -
Identifier Source: org_study_id