Tailored Radiofrequency Ablation of Uterine Myomas

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiofrequency myolysis of uterine fibroids<br>54 premenopausal participants with symptomatic uterine myomas | Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS<br>* 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<br>* Other names: RF lesion generator for tissue ablation during surgical procedures. Sterile single-use RF coagulation monopolar electrode.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myoma volumes after radiofrequency myolysis (RFM) | The outcomes evaluated after RFM were myoma volumes (cubic centimeters) | 12 months | 
| Myoma diameters after radiofrequency myolysis (RFM) | The outcomes evaluated after RFM were myoma diameters (centimeters) | 12 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time of radiofrequency myolysis (RFM) | The surgical time (minutes) for each different type of surgical access | 12 months | 
| 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 | 
| Pre-intervention biopsy associated to radiofrequency myolysis (RFM) | The number of biopsies for treated fibroma | 12 months |