Status:
UNKNOWN
High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids
Lead Sponsor:
Chongqing Medical University
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.
Detailed Description
Uterine fibroids (leiomyomas) are common in reproductive aged women. Patients are seeking new ways to treat symptomatic uterine fibroids that allow them to avoid surgery. High intensity focused ultras...
Eligibility Criteria
Inclusion
- Age 18 to 45; The size of fibroid situated at anterior wall not lower than 2 cm in MRI feature; The size of fibroid situated at posterior wall not lower than 4 cm in MRI feature.
Exclusion
- Cervical fibroids; Subserosal fibroids with pedicle, the width of pedicle≤ 2cm; Type 0 submucosal fibroids according to European Gynecologic Endoscopy classification; Combined with acute reproductive inflammation, or other benign and malignant gynecological diseases such as endometriosis, ovarian cancer; Pregnant (pregnancy test is positive), and lactating women; Allergy to MRI contrast agent; The history of collagen connective tissue, radiotherapy, especially abdominal radiotherapy; Surgical and anesthetic contraindications such as serious cardiac, vascular and other systemic diseases; Poor compliance; Patients who are not subject to experimental design.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01239641
Start Date
September 1 2010
End Date
July 1 2013
Last Update
November 15 2010
Active Locations (1)
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1
The 1st Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000