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Active Not Recruiting NCT07923253

Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids

Conditions: Leiomyoma (Uterine Fibroids)

Sex: Female
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: University of Novi Sad

Location: Clinic for Gynecology and Obstetrics, University Clinical Center of Vojvodina, Novi Sad, Serbia Novi Sad

Summary

This study evaluates the effectiveness and safety of transvaginal radiofrequency ablation of myomas (TVRFAM), a minimally invasive treatment for uterine fibroids performed at our clinic as part of the study. Women with uterine fibroids who meet the study eligibility criteria are invited to participate. The study includes women with fibroids classified as FIGO types 3-5, measuring 2-10 cm in diameter. Up to three fibroids may be treated during a single procedure. Written informed consent is obtained from all participants before enrollment. Before treatment, participants complete the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire, which assesses fibroid-related symptoms and their impact on daily life. Participants are followed for 12 months after treatment, with follow-up visits at 1, 3, 6, and 12 months. At each visit, a transvaginal ultrasound examination is performed to measure the volume of the treated fibroids. Participants also complete the UFS-QOL questionnaire to assess changes in their symptoms and quality of life over time. Complications occurring during the procedure are recorded. Information on pain after treatment, the duration of pain-relieving medication use, and any postoperative complications or other unwanted effects is also collected during follow-up. The main aim of the study is to measure the percentage reduction in fibroid volume following treatment. The study also evaluates changes in symptoms and quality of life, pain after the procedure, use of pain-relieving medication, and any complications or unwanted effects during the 12-month follow-up period.

Eligibility Criteria

Inclusion Criteria: * Adult women (18 years of age or older). * Women with uterine fibroids classified as FIGO types 3-5 * Uterine fibroids measuring 2-10 cm in diameter. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Women younger than 18 years of age. * Postmenopausal women. * Pregnant women. * Uterine fibroids outside the eligible FIGO types (3-5) or size range (2-10 cm in diameter). * Uterine fibroids with suspicious imaging features suggestive of uterine sarcoma. * Known or suspected gynecological malignancy or premalignant gynecological conditions. * Presence of an intrauterine device (IUD). * Active pelvic infection.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07923253). StuddyBuddy aggregates publicly available trial information.