NCT04091529

Tailored Radiofrequency Ablation of Uterine Myomas

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: International Evangelical Hospital · Academic / Other
• Sex: Female
• Age: 30 Years – 62 Years
• Healthy volunteers: Accepted

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.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-01
• Completion: 2019-03-31
• First posted: 2019-09-16
• Last updated: 2019-09-18

Locations

1 site across 1 country: Italy