Clinical trial NCT04091529: Tailored Radiofrequency Ablation of Uterine Myomas
Official title: A Prospective Study on Radiofrequency Ablation of Uterine Fibroids (Myolysis) Under Ultrasound and Endoscopic Guidance, in Single or Combined Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Lead sponsor: International Evangelical Hospital
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 54
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To perform the use of radiofrequency myolysis (RFM) for the treatment of intra-uterine fibroids through less invasive access by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy

Detailed description: Given that the RF ablation of solid tumors of the liver and other organs is successfully used as a usual approach, the investigators have decided to transfer this technology to an original treatment of uterine fibroids. The access to each individual fibroid was determined considering passage of the needle towards its centre through only compromised tissue and by the shortest possible route by combining trans-vaginal ultrasound, hysteroscopy and laparoscopy. To optimize radiofrequency myolysis, in fact, the investigators decided to improve the procedure by inserting three innovative elements: application of a virtual needle tracking system to follow the RF electrode during the ablation session, real-time monitoring of RF ablation by contrast-enhanced ultrasound and systematic biopsy of the lesions before electro-coagulation.

Eligibility criteria: "Inclusion Criteria":

* women who had symptomatic myomas with diameters ranging between 1.2 and 7.7 cm. - patients who had declined hysterectomy or laparoscopic myomectomy
* submucosal fibroids with intramural extension ≥50%
* intramural fibroids (FIGO G3 / G4 types)
* subserosal fibroids (FIGO G5 / G6 types)

"Exclusion Criteria":

* Women with intracavitary (FIGO G0 / G1 types) or subserosal-pedunculated fibroids / (FIGO G7 types)
* genital malignancy
* cervical dysplasias
* pelvic infection / adhesions
* severe systemic diseases
* pregnancy
* deeply infiltrating endometriosis
* patients who took gonadotropin-releasing hormone therapy or acetate ulipristal within 6 months

Primary outcomes:
measure: Myoma volumes after radiofrequency myolysis (RFM)
timeFrame: 12 months
measure: Myoma diameters after radiofrequency myolysis (RFM)
timeFrame: 12 months
measure: Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score after radiofrequency myolysis (RFM)
timeFrame: 12 months
Secondary outcomes:
measure: Surgical time of radiofrequency myolysis (RFM)
timeFrame: 12 months
measure: Surgical time of radiofrequency myolysis (RFM) assisted by new technologies
timeFrame: 12 months
measure: Pre-intervention biopsy associated to radiofrequency myolysis (RFM)
timeFrame: 12 months
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: International Evangelical Hospital
Study officials:
affiliation: International Evangelical Hospital
name: Alessandro FASCIANI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.
citation: Toub DB. A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System. Curr Obstet Gynecol Rep. 2017;6(1):67-73. doi: 10.1007/s13669-017-0194-2. Epub 2017 Feb 15.
citation: Yin G, Chen M, Yang S, Li J, Zhu T, Zhao X. Treatment of uterine myomas by radiofrequency thermal ablation: a 10-year retrospective cohort study. Reprod Sci. 2015 May;22(5):609-14. doi: 10.1177/1933719114556481. Epub 2014 Oct 29.
citation: Lin L, Ma H, Wang J, Guan H, Yang M, Tong X, Zou Y. Quality of Life, Adverse Events, and Reintervention Outcomes after Laparoscopic Radiofrequency Ablation for Symptomatic Uterine Fibroids: A Meta-Analysis. J Minim Invasive Gynecol. 2019 Mar-Apr;26(3):409-416. doi: 10.1016/j.jmig.2018.09.772. Epub 2018 Sep 22.
citation: Turtulici G, Orlandi D, Dedone G, Mauri G, Fasciani A, Sirito R, Silvestri E. Ultrasound-guided transvaginal radiofrequency ablation of uterine fibroids assisted by virtual needle tracking system: a preliminary study. Int J Hyperthermia. 2019 Jan 1;35(1):97-104. doi: 10.1080/02656736.2018.1479778. Epub 2018 Jul 17.