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High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

NCT ID: NCT01239641

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Uterine Fibroid

Keywords

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Uterine Fibroids Myoectomy High Intensity Focused Ultrasound ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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myomectomy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chongqing Medical University

Principal Investigators

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LD Tang, PhD

Role: STUDY_CHAIR

the first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecolog

Z B wang, PhD

Role: STUDY_DIRECTOR

Biomedical Engineering Department of Chongqing Medical University

Wen-Zhi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Center for Tumor Therapy, the 2nd Hospital of Chongqing Medical University

Jin-Yun Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Engineering Department of Chongqing Medical University

Min Zhou, PhD

Role: PRINCIPAL_INVESTIGATOR

The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology

Juan Qin, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Engineering Department, Chongqing Medical University

Xiaoyan Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology

Locations

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The 1st Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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LD Tang, PhD

Role: primary

JINYUN CHEN, PhD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 23564052 (View on PubMed)

Other Identifiers

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30901234

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H2610

Identifier Type: -

Identifier Source: org_study_id