Tailored Radiofrequency Ablation of Uterine Myomas

International Evangelical Hospital

Status: Completed

Conditions: Uterine Fibroids

Treatments: Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS

Study type: Interventional

Funder types: Other

Identifiers

NCT04091529

295/2018

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 30 to 62 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

"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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Radiofrequency myolysis of uterine fibroids

Experimental group

Description:

54 premenopausal participants with symptomatic uterine myomas

Treatment:

Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS