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Uterine FibroidsNCT04091529

Tailored Radiofrequency Ablation of Uterine Myomas

A study testing RADIOFREQUENCY ABLATION OF UTERINE MYOMAS in people with Uterine Fibroids, run by International Evangelical Hospital at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 30 to 62 years, women onlyHealthy volunteers can take part
Conditions the study is for
Uterine Fibroids
What is being tested?
RADIOFREQUENCY ABLATION OF UTERINE MYOMAS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteItaly
Study dates
1 Mar 2017to 31 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 62 years
  • Women only
  • Healthy volunteers accepted
  • Adult

"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 locations and contacts

1 site in 1 country.

Italy1 site

  • International Evangelical Hospital

    Genoa, 16125

Other trials in Italy

About this study

Official title: 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

Read the 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.

Being tested
RADIOFREQUENCY ABLATION OF UTERINE MYOMAS
Medical subject headings
Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RADIOFREQUENCY ABLATION OF UTERINE MYOMASDevice

    Also called Radiofrequency myolysis (RFM), RF lesion generator for tissue ablation during surgical procedures. Sterile single-use RF coagulation monopolar electrode.

    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

Study groups in NCT04091529
Study groupRoleWhat they receive
Radiofrequency myolysis of uterine fibroidsExperimental54 premenopausal participants with symptomatic uterine myomas
Receives: Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myoma volumes after radiofrequency myolysis (RFM)

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

    Measured: 12 months

  2. Myoma diameters after radiofrequency myolysis (RFM)

    The outcomes evaluated after RFM were myoma diameters (centimeters)

    Measured: 12 months

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

    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.

    Measured: 12 months

Secondary outcomes (3)

  1. Surgical time of radiofrequency myolysis (RFM)

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

    Measured: 12 months

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

    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

    Measured: 12 months

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

    The number of biopsies for treated fibroma

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2019
  2. Study start1 Mar 2017
  3. Primary completion1 Mar 2019
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091529
Sponsor's protocol ID
295/2018
Status last verified
Sep 2019
First submitted
21 Jul 2019
Last updated
18 Sep 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stewart EA, Lytle BL, Thomas L, Wegienka GR, Jacoby V, Diamond MP, Nicholson WK, Anchan RM, Venable S, Wallace K, Marsh EE, Maxwell GL, Borah BJ, Catherino WH, Myers ER. The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design. Am J Obstet Gynecol. 2018 Jul;219(1):95.e1-95.e10. doi: 10.1016/j.ajog.2018.05.004. Epub 2018 May 8.

    PubMed 29750955

  • Toub DB. A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata System. Curr Obstet Gynecol Rep. 2017;6(1):67-73. doi: 10.1007/s13669-017-0194-2. Epub 2017 Feb 15.

    PubMed 28357157

  • Yin G, Chen M, Yang S, Li J, Zhu T, Zhao X. Treatment of uterine myomas by radiofrequency thermal ablation: a 10-year retrospective cohort study. Reprod Sci. 2015 May;22(5):609-14. doi: 10.1177/1933719114556481. Epub 2014 Oct 29.

    PubMed 25355802

  • Lin L, Ma H, Wang J, Guan H, Yang M, Tong X, Zou Y. Quality of Life, Adverse Events, and Reintervention Outcomes after Laparoscopic Radiofrequency Ablation for Symptomatic Uterine Fibroids: A Meta-Analysis. J Minim Invasive Gynecol. 2019 Mar-Apr;26(3):409-416. doi: 10.1016/j.jmig.2018.09.772. Epub 2018 Sep 22.

    PubMed 30253997

  • Turtulici G, Orlandi D, Dedone G, Mauri G, Fasciani A, Sirito R, Silvestri E. Ultrasound-guided transvaginal radiofrequency ablation of uterine fibroids assisted by virtual needle tracking system: a preliminary study. Int J Hyperthermia. 2019 Jan 1;35(1):97-104. doi: 10.1080/02656736.2018.1479778. Epub 2018 Jul 17.

    PubMed 30012030

Questions about this trial

What is this clinical trial studying?

A study testing RADIOFREQUENCY ABLATION OF UTERINE MYOMAS in people with Uterine Fibroids, run by International Evangelical Hospital at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myoma volumes after radiofrequency myolysis (RFM) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091529, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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