Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tailored Radiofrequency Ablation of Uterine Myomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091529
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Alessandro FASCIANI, 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

Condition or disease Intervention/treatment Phase
Uterine Fibroids Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study on Radiofrequency Ablation of Uterine Fibroids (Myolysis) Under Ultrasound and Endoscopic Guidance, in Single or Combined Approach
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 31, 2019

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 62 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091529


Locations
Layout table for location information
Italy
International Evangelical Hospital
Genoa, Italy, 16125
Sponsors and Collaborators
International Evangelical Hospital
Investigators
Layout table for investigator information
Principal Investigator: Alessandro FASCIANI International Evangelical Hospital

Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Alessandro FASCIANI, MD - Principal Investigator, International Evangelical Hospital
ClinicalTrials.gov Identifier: NCT04091529     History of Changes
Other Study ID Numbers: 295/2018
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases