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Completed

NCT Number: NCT04091529

Tailored Radiofrequency Ablation of Uterine Myomas

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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Key information

Age range

30 year–62 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

International Evangelical Hospital

Genoa, 16125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

"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

Treatment and study plan

RADIOFREQUENCY ABLATION OF UTERINE MYOMAS

Device

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.

Primary outcomes

  1. Myoma volumes after radiofrequency myolysis (RFM)

    Time frame: 12 months

    The outcomes evaluated after RFM were myoma volumes (cubic centimeters)

  2. Myoma diameters after radiofrequency myolysis (RFM)

    Time frame: 12 months

    The outcomes evaluated after RFM were myoma diameters (centimeters)

  3. Uterine Fibroid Symptom and Quality of Life (UFS-QOL) score after radiofrequency myolysis (RFM)

    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.

Secondary outcomes

  1. Surgical time of radiofrequency myolysis (RFM)

    Time frame: 12 months

    The surgical time (minutes) for each different type of surgical access

  2. Surgical time of radiofrequency myolysis (RFM) assisted by new technologies

    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

  3. Pre-intervention biopsy associated to radiofrequency myolysis (RFM)

    Time frame: 12 months

    The number of biopsies for treated fibroma

Sponsors and collaborators

Lead sponsor

International Evangelical Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2019
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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