Tailored Radiofrequency Ablation of Uterine Myomas

Not Applicable

Completed

• Conditions: Uterine Fibroids
• Interventions: Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS

• Registration Number: NCT04091529
• Lead Sponsor: International Evangelical Hospital

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-31
• Study First Submitted: 2019-07-21
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiofrequency myolysis of uterine fibroids	RADIOFREQUENCY ABLATION OF UTERINE MYOMAS	54 premenopausal participants with symptomatic uterine myomas

Primary Outcome Measures

Name	Time	Method
Myoma volumes after radiofrequency myolysis (RFM)	12 months	The outcomes evaluated after RFM were myoma volumes (cubic centimeters)
Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score after radiofrequency myolysis (RFM)	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.
Myoma diameters after radiofrequency myolysis (RFM)	12 months	The outcomes evaluated after RFM were myoma diameters (centimeters)

Secondary Outcome Measures

Name	Time	Method
Surgical time of radiofrequency myolysis (RFM) assisted by new technologies	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
Surgical time of radiofrequency myolysis (RFM)	12 months	The surgical time (minutes) for each different type of surgical access
Pre-intervention biopsy associated to radiofrequency myolysis (RFM)	12 months	The number of biopsies for treated fibroma

Trial Locations

Locations (1)

International Evangelical Hospital; 🇮🇹 Genoa, Italy