Radio Frequency Ablation (RFA STUDY )

Uterine Myoma Clinical Trial

— RFA  

Official title:

Tissue Effect in Extirpated Uterine Fibroid Tissue Using Existing Olympus Radiofrequency Probes for Fibroids Ablation (Radio Frequency Ablation RFA STUDY )

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02631278
• Other study ID #: 4962/14
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: December 11, 2015
• Start date: December 2014
• Est. completion date: August 2017

Study information

• Verified date: December 2015
• Source: Catholic University of the Sacred Heart
• Contact: Giovanni Scambia, MD
• Phone: +390630154979
• Email: giovanni.scambia[@]rm.unicatt.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Myoma

Intervention

Device:
• Intraoperative radiofrequency ablation
Intra-operative Radiofrequency ablation will be carried out and followed by surgical removal of the treated leiomyoma.

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome
Italy	Catholic University of Sacred Heart Rome,	Rome,	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Olympus Winter & Ibe

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

Gazelle GS, Goldberg SN, Solbiati L, Livraghi T. Tumor ablation with radio-frequency energy. Radiology. 2000 Dec;217(3):633-46. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes