Clinical trial NCT01239641: High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids
Official title: Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Uterine Fibroid
Keywords: Uterine Fibroids
Myoectomy
High Intensity Focused Ultrasound
ablation
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ultrasound therapy (HIFU) is a novel non-invasive method for uterine fibroid. Preliminary clinical studies proved HIFU ablation is a safe and effective technology. However, it is not clear whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.The study is to confirm these questions.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: The quality of life, adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Fibroid volume ablated
timeFrame: any time
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The 1st Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: the first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecolog
name: LD Tang, PhD
role: STUDY_CHAIR
affiliation: Biomedical Engineering Department of Chongqing Medical University
name: Z B wang, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Center for Tumor Therapy, the 2nd Hospital of Chongqing Medical University
name: Wen-Zhi Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Engineering Department of Chongqing Medical University
name: Jin-Yun Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology
name: Min Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Engineering Department, Chongqing Medical University
name: Juan Qin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology
name: Xiaoyan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang X, Qin J, Wang L, Chen J, Chen W, Tang L. Effect of high-intensity focused ultrasound on sexual function in the treatment of uterine fibroids: comparison to conventional myomectomy. Arch Gynecol Obstet. 2013 Oct;288(4):851-8. doi: 10.1007/s00404-013-2775-2. Epub 2013 Apr 7.