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High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

Primary Purpose

Uterine Fibroid

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

High intensity focused ultrasound

About this trial

This is an interventional treatment trial for Uterine Fibroid focused on measuring Uterine Fibroids, Myoectomy, High Intensity Focused Ultrasound, ablation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

The 1st Hospital of Chongqing Medical UniversityRecruiting

Outcomes

Primary Outcome Measures

The quality of life, adverse events

Secondary Outcome Measures

Fibroid volume ablated

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

Full Information

NCT ID

NCT01239641

First Posted

November 10, 2010

Last Updated

November 12, 2010

Sponsor

Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01239641

Brief Title

High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Unknown status

Study Start Date

September 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Chongqing Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroid

Keywords

Uterine Fibroids, Myoectomy, High Intensity Focused Ultrasound, ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

High intensity focused ultrasound

Other Intervention Name(s)

myomectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

The quality of life, adverse events

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Fibroid volume ablated

Description

Time Frame

any time

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LD Tang, PhD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Z B wang, PhD

Organizational Affiliation

Biomedical Engineering Department of Chongqing Medical University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Wen-Zhi Chen, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jin-Yun Chen, PhD

Organizational Affiliation

Biomedical Engineering Department of Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Min Zhou, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juan Qin, PhD

Organizational Affiliation

Biomedical Engineering Department, Chongqing Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaoyan Wang, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

The 1st Hospital of Chongqing Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LD Tang, PhD

Phone

13628460069

ldtang2002@yahoo.com

First Name & Middle Initial & Last Name & Degree

JINYUN CHEN, PhD

Phone

13668029697

chenjinyun2006@126.com

First Name & Middle Initial & Last Name & Degree

Wen-Zhi Chen, MD

First Name & Middle Initial & Last Name & Degree

Jin Yun Chen, PhD

First Name & Middle Initial & Last Name & Degree

Min Zhou, PhD

First Name & Middle Initial & Last Name & Degree

Juan Qin, PhD

First Name & Middle Initial & Last Name & Degree

Xiaoyan Wang, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23564052

Citation

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.

Results Reference

derived

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High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

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