Clinical trial · Interventional
Tailored Radiofrequency Ablation of Uterine Myomas
A Prospective Study on Radiofrequency Ablation of Uterine Fibroids (Myolysis) Under Ultrasound and Endoscopic Guidance, in Single or Combined Approach
NCT04091529CI-TRIAL-00040682completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RADIOFREQUENCY ABLATION OF UTERINE MYOMAS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiofrequency myolysis of uterine fibroids
- description
- 54 premenopausal participants with symptomatic uterine myomas
- interventionNames
- Device: RADIOFREQUENCY ABLATION OF UTERINE MYOMAS
Primary outcomes (3)
- measure
- Myoma volumes after radiofrequency myolysis (RFM)
- timeFrame
- 12 months
- description
- The outcomes evaluated after RFM were myoma volumes (cubic centimeters)
- measure
- Myoma diameters after radiofrequency myolysis (RFM)
- timeFrame
- 12 months
- description
- The outcomes evaluated after RFM were myoma diameters (centimeters)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 62 Years
Show eligibility criteria text
"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
References
Publications (5)
- BACKGROUNDStewart 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
- BACKGROUNDToub 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
- BACKGROUNDYin 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
- BACKGROUNDLin 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
- RESULTTurtulici 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