International Evangelical Hospital
Genoa, 16125, Italy
NCT Number: NCT04091529
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
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Notify Me30 year–62 year
Female
Interventional
Not applicable
Genoa, 16125, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
"Inclusion Criteria":
"Exclusion Criteria":
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
Other names: Radiofrequency myolysis (RFM), RF lesion generator for tissue ablation during surgical procedures. Sterile single-use RF coagulation monopolar electrode.
Time frame: 12 months
The outcomes evaluated after RFM were myoma volumes (cubic centimeters)
Time frame: 12 months
The outcomes evaluated after RFM were myoma diameters (centimeters)
Time frame: 12 months
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.
Time frame: 12 months
The surgical time (minutes) for each different type of surgical access
Time frame: 12 months
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
Time frame: 12 months
The number of biopsies for treated fibroma
International Evangelical Hospital
Other
A Prospective Study on Radiofrequency Ablation of Uterine Fibroids (Myolysis) Under Ultrasound and Endoscopic Guidance, in Single or Combined Approach
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