Radio Frequency Ablation (RFA STUDY )

Not Applicable

• Conditions: Uterine Myoma
• Interventions: Device: Intraoperative radiofrequency ablation

• Registration Number: NCT02631278
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-01-19
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-11
• Last Update Submitted: 2015-12-11
• Study First Posted: 2015-12-16
• Last Update Posted: 2015-12-16
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Intraoperative radiofrequency ablation	Intraoperative radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
Estimation termal dose	Intraoperative time	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.

Trial Locations

Locations (2)

Catholic University of Sacred Heart Rome,; 🇮🇹 Rome,, Rome, Italy

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy