High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

Sponsor

Chongqing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01239641

Collaborator

(none)

220

Enrollment

Location

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Sep 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Jul 1, 2013

Outcome Measures

Primary Outcome Measures

The quality of life, adverse events [1 year]

Secondary Outcome Measures

Fibroid volume ablated [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

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The 1st Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400000

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