Radio Frequency Ablation (RFA STUDY )

NCT02631278 | Unknown DMC

• 1 other identifier: 4962/14
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Uterine Myoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

single arm

OTHER

Intraoperative radiofrequency ablation

Device: Intraoperative radiofrequency ablation

Interventions

Intraoperative radiofrequency ablation DEVICE

Intra-operative Radiofrequency ablation will be carried out and followed by surgical removal of the treated leiomyoma.

Also known as: The CelonPower system Olympus

single arm

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• premenopausal women, 25 years of age or older;
• presence of fibroid-related symptoms (menorrhagia, pelvic pain and/or bulk symptoms) not responsive to medical therapy;
• uteri \<20-week gestational size on pelvic examination;
• one myoma 5-15 cm in diameter as measured by transvaginal ultrasound;
• desire for uterine preservation;
• normal coagulation profile;
• normal Pap test result in the last year,
• hemoglobin level of 10.0 g/dL or more at the time of treatment.

You may not qualify if:

• pedunculated subserosal or intracavitary myomas,
• a history of pelvic malignancy,
• presence of cervical dysplasia,
• a prior procedure to treat or remove myomas,
• contraindications to general anesthesia or abdominal surgery.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Olympus Winter & Ibe: collaborator

Study Sites (2)

Catholic University of Sacred Heart Rome,

Rome, Rome, 00100, Italy

RECRUITING

Catholic University of Sacred Heart

Rome, Rome, 00100, Italy

RECRUITING

Related 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. doi: 10.1016/j.ajog.2004.10.591.

  PMID: 15746670 BACKGROUND

• 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.

  PMID: 11324771 BACKGROUND

• 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.

  PMID: 11110923 BACKGROUND

• 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.

  PMID: 8056027 BACKGROUND

• 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.

  PMID: 9806586 BACKGROUND

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giovanni Scambia, MD

  Catholic University of Sacred Heart - Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Scambia, MD

CONTACT

+390630154979; giovanni.scambia@rm.unicatt.it

Cristiano Rossitto, MD

CONTACT

+390630154979; cristiano.rossitto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

IT (2)