Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
Phase 2/Phase 3
20 Years
50 Years
20 Years
50 Years
Open (Enrolling by invite only)
Female
Leiomyoma
Female
Leiomyoma
Trial Information
Multi-Center Clinical Trial of Uterine Artery Embolization Treatment of Uterine Leiomyoma
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
quality of life
Outcome Time Frame:
1,3,5,10 year.
Safety Issue:
No
Principal Investigator
Hong Shan, M.D., PHD.
Investigator Role:
Study Director
Investigator Affiliation:
Third Affiliated Hospital, Sun Yat-Sen University
Authority:
China: Ministry of Health
Study ID:
2007026
NCT ID:
NCT00821275
Start Date:
January 2008
Completion Date:
December 2018
Related Keywords:
- Leiomyoma
- Uterine Artery Embolization
- Leiomyoma
- myomectomy
- hysterectomy
- pregnancy
- complication
- ovarian function
- quality of life
- Leiomyoma
- Myofibroma
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