High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.

Condition or disease	Intervention/treatment	Phase
Uterine Fibroid	Procedure: High intensity focused ultrasound	Phase 4

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.

Study Design

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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

Arms and Interventions

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Intervention Details:

Procedure: High intensity focused ultrasound
The term 'high intensity focused ultrasound' means using ultrasound to causes coagulation necrosis to destroy the targeted tissue, in this case, uterine fibroids.
Other Name: myomectomy

Outcome Measures

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Primary Outcome Measures :

1. The quality of life, adverse events [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Chongqing Medical University

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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