High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by Chongqing Medical University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT01239641

First received: November 10, 2010

Last updated: November 12, 2010

Last verified: November 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Uterine Fibroid	Procedure: High intensity focused ultrasound	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound Uterine Fibroids

U.S. FDA Resources

Further study details as provided by Chongqing Medical University:

Primary Outcome Measures:

The quality of life, adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fibroid volume ablated [ Time Frame: any time ] [ Designated as safety issue: Yes ]
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


Estimated Enrollment:	220
Study Start Date:	September 2010
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Chongqing Medical University

Additional 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
Study First Received:	November 10, 2010
Last Updated:	November 12, 2010
Health Authority:	China: National Natural Science Foundation

Keywords provided by Chongqing Medical University:


Uterine Fibroids Myoectomy High Intensity Focused Ultrasound ablation

Additional relevant MeSH terms:


Leiomyoma Myofibroma Connective Tissue Diseases Neoplasms	Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on February 27, 2015

To Top