Uterine FibroidPhase 4NCT01239641
High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids
A Phase 4 study testing High intensity focused ultrasound in people with Uterine Fibroid, run by Chongqing Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Fibroid
- What is being tested?
- High intensity focused ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 1st Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
LD Tang, PhD, 13628460069, ldtang2002@yahoo.com
JINYUN CHEN, PhD, 13668029697, chenjinyun2006@126.com
About this study
Official title: Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study
The purpose of this study is to determine whether HIFU has superiority over traditional surgery on satisfaction and adverse impact.
Read the 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.
- Conditions
- Uterine Fibroid
- Being tested
- High intensity focused ultrasound
- Keywords
- Uterine Fibroids, Myoectomy, High Intensity Focused Ultrasound, ablation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity focused ultrasoundProcedure or surgery
Also called myomectomy
The term 'high intensity focused ultrasound' means using ultrasound to causes coagulation necrosis to destroy the targeted tissue, in this case, uterine fibroids.
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life, adverse events
Measured: 1 year
Secondary outcomes (1)
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
Measured: any time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- LD Tang, PhD, Study chair, the first affiliated Chongqing University Hospital, Dept of Obstetrics and GynecologZ B wang, PhD, Study director, Biomedical Engineering Department of Chongqing Medical UniversityWen-Zhi Chen, MD, Principal investigator, Clinical Center for Tumor Therapy, the 2nd Hospital of Chongqing Medical UniversityJin-Yun Chen, PhD, Principal investigator, Biomedical Engineering Department of Chongqing Medical UniversityMin Zhou, PhD, Principal investigator, The first affiliated Chongqing University Hospital, Dept of Obstetrics and GynecologyJuan Qin, PhD, Principal investigator, Biomedical Engineering Department, Chongqing Medical UniversityXiaoyan Wang, PhD, Principal investigator, The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239641
- Sponsor's protocol ID
- H2610
- Other IDs
- 30901234
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23564052
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01239641
- Acronym / sponsor ID
- H2610
- Conditions
- Uterine Fibroid
- Keywords
- Uterine Fibroids, Myoectomy, High Intensity Focused Ultrasound, ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity focused ultrasoundAlso: myomectomyThe term 'high intensity focused ultrasound' means using ultrasound to causes coagulation necrosis to destroy the targeted tissue, in this case, uterine fibroids. | Procedure or surgery | – |
Primary outcome
The quality of life, adverse events
Time frame: 1 year
1 secondary outcome
Fibroid volume ablated
Time frame: any time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- Derived from this study: PubMed 23564052Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LD Tang, PhD study chair
the first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecolog
Z B wang, PhD study director
Biomedical Engineering Department of Chongqing Medical University
Wen-Zhi Chen, MD principal investigator
Clinical Center for Tumor Therapy, the 2nd Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High intensity focused ultrasound in people with Uterine Fibroid, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of life, adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2010; AzTrials last refreshed its copy on 8 Nov 2026.