Tailored Radiofrequency Ablation of Uterine Myomas

Uterine Fibroids Clinical Trial

Official title:

A Prospective Study on Radiofrequency Ablation of Uterine Fibroids (Myolysis) Under Ultrasound and Endoscopic Guidance, in Single or Combined Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091529
• Other study ID #: 295/2018
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: September 2019
• Source: International Evangelical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 31, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 62 Years

Eligibility

"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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Device:
• RADIOFREQUENCY ABLATION OF UTERINE MYOMAS
The ablation device consisted of an radiofrequency (RF) energy generator (STARmed, RF generator VRS01) and an electric pump for the continuous cooling of the electrode tip. The RF generator to which the electrode (STARmed Gyeonggi-Do, Korea) is connected displays simultaneously the temperature of the electrode tip, the tissue impedance characteristics, the power and the ablation time. A 35 cm long 18Gauge internally cooled electrode with an exposed tip of 10 mm or a variable exposed tip was used

Locations

Country	Name	City	State
Italy	International Evangelical Hospital	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
International Evangelical Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View 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. — View 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. Review. — View 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): — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myoma volumes after radiofrequency myolysis (RFM)	The outcomes evaluated after RFM were myoma volumes (cubic centimeters)	12 months
Primary	Myoma diameters after radiofrequency myolysis (RFM)	The outcomes evaluated after RFM were myoma diameters (centimeters)	12 months
Primary	Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score after radiofrequency myolysis (RFM)	Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire with scores ranging from 0 to 100, were higher QOL scores mean a better health-related QOL 1 and a 10-point scale used for each reported symptom.	12 months
Secondary	Surgical time of radiofrequency myolysis (RFM)	The surgical time (minutes) for each different type of surgical access	12 months
Secondary	Surgical time of radiofrequency myolysis (RFM) assisted by new technologies	The reduction of surgical time (minutes) with the use of a virtual global positioning system (GPS) track system or a contrast-enhanced ultrasound during the ablation	12 months
Secondary	Pre-intervention biopsy associated to radiofrequency myolysis (RFM)	The number of biopsies for treated fibroma	12 months