Tailored Radiofrequency Ablation of Uterine Myomas

September 16, 2019 updated by: Alessandro FASCIANI, International Evangelical Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Genoa, Italy, 16125
        • International Evangelical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

"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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency myolysis of uterine fibroids
54 premenopausal participants with symptomatic uterine myomas
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
Other Names:
  • Radiofrequency myolysis (RFM)
  • RF lesion generator for tissue ablation during surgical procedures. Sterile single-use RF coagulation monopolar electrode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myoma volumes after radiofrequency myolysis (RFM)
Time Frame: 12 months
The outcomes evaluated after RFM were myoma volumes (cubic centimeters)
12 months
Myoma diameters after radiofrequency myolysis (RFM)
Time Frame: 12 months
The outcomes evaluated after RFM were myoma diameters (centimeters)
12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical time of radiofrequency myolysis (RFM)
Time Frame: 12 months
The surgical time (minutes) for each different type of surgical access
12 months
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
12 months
Pre-intervention biopsy associated to radiofrequency myolysis (RFM)
Time Frame: 12 months
The number of biopsies for treated fibroma
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Evangelical Hospital

Investigators

  • Principal Investigator: Alessandro FASCIANI, International Evangelical Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

September 13, 2019

First Posted (Actual)

September 16, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 295/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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