High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

November 12, 2010 updated by: Chongqing Medical University

Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • The 1st Hospital of Chongqing Medical University
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The quality of life, adverse events
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
any time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 11, 2010

Study Record Updates

Last Update Posted (Estimate)

November 15, 2010

Last Update Submitted That Met QC Criteria

November 12, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2610
  • 30901234 (Other Grant/Funding Number: Nature Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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