Status:
COMPLETED
Tailored Radiofrequency Ablation of Uterine Myomas
Lead Sponsor:
International Evangelical Hospital
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
30-62 years
Phase:
NA
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
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 o...
Eligibility Criteria
Inclusion
- "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
Exclusion
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04091529
Start Date
March 1 2017
End Date
March 31 2019
Last Update
September 18 2019
Active Locations (1)
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1
International Evangelical Hospital
Genoa, Italy, 16125