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High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Chongqing Medical University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Chongqing Medical University
Information provided by:
Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01239641
First received: November 10, 2010
Last updated: November 12, 2010
Last verified: November 2010
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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 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:
Further study details as provided by Chongqing Medical University:
Primary Outcome Measures:
- The quality of life, adverse events [ Time Frame: 1 year ]
Secondary Outcome Measures:
- 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
| 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:
Detailed Description:
-
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.
Other Name: myomectomy
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 (Adult) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01239641
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ZB Wang, Chongqing Medical University |
| ClinicalTrials.gov Identifier: | NCT01239641 History of Changes |
| Other Study ID Numbers: |
H2610 30901234 ( Other Grant/Funding Number: Nature Science Foundation of China ) |
| Study First Received: | November 10, 2010 |
| Last Updated: | November 12, 2010 |
Keywords provided by Chongqing Medical University:
|
Uterine Fibroids Myoectomy High Intensity Focused Ultrasound ablation |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on June 26, 2017