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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01239641
Other study ID # H2610
Secondary ID 30901234
Status Recruiting
Phase Phase 4
First received November 10, 2010
Last updated November 12, 2010
Start date September 2010
Est. completion date July 2013

Study information

Verified date November 2010
Source Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date July 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

Country Name City State
China The 1st Hospital of Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The quality of life, adverse events 1 year No
Secondary 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 any time Yes
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