High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids
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ClinicalTrials.gov Identifier: NCT01239641 |
Recruitment Status
: Unknown
Verified November 2010 by Chongqing Medical University.
Recruitment status was: Recruiting
First Posted
: November 11, 2010
Last Update Posted
: November 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uterine Fibroid | Procedure: High intensity focused ultrasound | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study |
Study Start Date : | September 2010 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | July 2013 |
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Procedure: High intensity focused ultrasound
- The quality of life, adverse events [ Time Frame: 1 year ]
- Fibroid volume ablated [ Time Frame: any time ]Detection of serum markers of trauma, The change of immunological function,Procedure duration, Time to return to normal activity ,Recurrence, Reintevention rate and Pregnancy outcome, Female reproductive function, Sexual function and psychological change

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239641
China, Chongqing | |
The 1st Hospital of Chongqing Medical University | Recruiting |
Chongqing, Chongqing, China, 400000 | |
Contact: LD Tang, PhD 13628460069 ldtang2002@yahoo.com | |
Contact: JINYUN CHEN, PhD 13668029697 chenjinyun2006@126.com | |
Principal Investigator: Wen-Zhi Chen, MD | |
Principal Investigator: Jin Yun Chen, PhD | |
Sub-Investigator: Min Zhou, PhD | |
Sub-Investigator: Juan Qin, PhD | |
Sub-Investigator: Xiaoyan Wang, PhD |
Study Chair: | LD Tang, PhD | the first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecolog | |
Study Director: | Z B wang, PhD | Biomedical Engineering Department of Chongqing Medical University | |
Principal Investigator: | Wen-Zhi Chen, MD | Clinical Center for Tumor Therapy, the 2nd Hospital of Chongqing Medical University | |
Principal Investigator: | Jin-Yun Chen, PhD | Biomedical Engineering Department of Chongqing Medical University | |
Principal Investigator: | Min Zhou, PhD | The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology | |
Principal Investigator: | Juan Qin, PhD | Biomedical Engineering Department, Chongqing Medical University | |
Principal Investigator: | Xiaoyan Wang, PhD | The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ZB Wang, Chongqing Medical University |
ClinicalTrials.gov Identifier: | NCT01239641 History of Changes |
Other Study ID Numbers: |
H2610 30901234 ( Other Grant/Funding Number: Nature Science Foundation of China ) |
First Posted: | November 11, 2010 Key Record Dates |
Last Update Posted: | November 15, 2010 |
Last Verified: | November 2010 |
Keywords provided by Chongqing Medical University:
Uterine Fibroids Myoectomy High Intensity Focused Ultrasound ablation |
Additional relevant MeSH terms:
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |