Tailored Radiofrequency Ablation of Uterine Myomas

NCT04091529 | Completed DMC

• 1 other identifier: 295/2018
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Uterine Fibroids

Outcome Measures

Primary Outcomes (3)

• Myoma volumes after radiofrequency myolysis (RFM)

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

  12 months

• Myoma diameters after radiofrequency myolysis (RFM)

  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)

  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 Outcomes (3)

• Surgical time of radiofrequency myolysis (RFM)

  12 months

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

  12 months

• Pre-intervention biopsy associated to radiofrequency myolysis (RFM)

  12 months

Study Arms (1)

Radiofrequency myolysis of uterine fibroids

EXPERIMENTAL

54 premenopausal participants with symptomatic uterine myomas

Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS

Interventions

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

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

Radiofrequency myolysis of uterine fibroids

Eligibility Criteria

• Age: 30 Years - 62 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• International Evangelical Hospital: lead

Study Sites (1)

International Evangelical Hospital

Genoa, 16125, Italy

Location

Related Publications (5)

• 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.

  PMID: 29750955 BACKGROUND

• 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.

  PMID: 28357157 BACKGROUND

• 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.

  PMID: 25355802 BACKGROUND

• 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.

  PMID: 30253997 BACKGROUND

• 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.

  PMID: 30012030 RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alessandro FASCIANI

  International Evangelical Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD - Principal Investigator

Study Record Dates

• First Submitted: July 21, 2019
• First Posted: September 16, 2019
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)