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High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:

Study Description
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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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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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


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

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