NCT00821275
Unknown
Phase 2
Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
Sun Yat-sen University4 sites in 1 country900 target enrollmentJanuary 2008
ConditionsLeiomyoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Leiomyoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 900
- Locations
- 4
- Primary Endpoint
- quality of life
- Last Updated
- 17 years ago
Overview
Brief Summary
The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of symptomatic uterine leiomyoma
Exclusion Criteria
- •pregnancy
- •iodine agent allergy
- •patient refuse to take part in this trial
- •tumour size is less than 3cm or beyond 10cm
- •with endometriosis
- •with malignant diseases
- •with abnormal coagulation function which can't restore
- •with acute inflammatory diseases or acute episode of chronic inflammatory diseases
- •with severe heart, lung, liver and kidney, et al. organ diseases.
Outcomes
Primary Outcomes
quality of life
Time Frame: 1,3,5,10 year.
pregnant
Time Frame: 3 years
Secondary Outcomes
- tumor recurrence(1,3,5,10 years)
- complications(3,6,12,24 months)
- ovarian functions(3,6,12 months, 2,3,5 and 10 years)
- symptom relief(3,6,12,24 months)
- tumour volume(3,6,12 18 24 months and 3,5,10 years)
Study Sites (4)
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