Radio Frequency Ablation (RFA STUDY ) (RFA)

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.

Study Overview

• Status: Unknown
• Conditions: Uterine Myoma
• Intervention / Treatment: Device: Intraoperative radiofrequency ablation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00100
    • Recruiting
    • Catholic University Of Sacred Heart
    • Contact: Catholic University of Sacred Heart
  • Rome
    • Rome,, Rome, Italy, 00100
      • Recruiting
      • Catholic University of Sacred Heart Rome,
      • Contact: Giovanni Scambia, Professor; Phone Number: +39-06-30156279; Email: giovanni.scambia@rm.unicatt.it
      • Sub-Investigator: Rossitto Cristiano, MD
      • Sub-Investigator: Tropeano Giovanna, MD
      • Sub-Investigator: Amoroso Sonia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. premenopausal women, 25 years of age or older;
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:

1. pedunculated subserosal or intracavitary myomas,
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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single arm; Intraoperative radiofrequency ablation	Device: Intraoperative radiofrequency ablation; Intra-operative Radiofrequency ablation will be carried out and followed by surgical removal of the treated leiomyoma.; Other Names: The CelonPower system Olympus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation termal dose	Specimens of fibroid will be fixed immediately in 10% neutral formaline solution for approximately 3h, then they will be 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.	Intraoperative time

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Olympus Winter & Ibe
• Investigators: Principal Investigator: Giovanni Scambia, MD, Catholic University of Sacred Heart - Rome

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: January 19, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: 4962/14