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Status unknownNCT01239641Updated Nov 15, 2010

High Intensity Focused Ultrasound Ablation Virus Myomectomy to Treat Uterine Fibroids

A Phase 4 interventional study of High intensity focused ultrasound in Uterine Fibroid, sponsored by Chongqing Medical University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2010-11-15.

Sponsored by Chongqing Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Uterine Fibroid

Keywords

  • Uterine Fibroids
  • Myoectomy
  • High Intensity Focused Ultrasound
  • ablation
03

In context

Leiomyoma

490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.

This study's planned enrollment of 220 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.

Browse Leiomyoma studies →

Lead sponsor

Chongqing Medical University is the lead sponsor of 75 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
220 participants (estimated)

Interventions

  • ProcedureHigh 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.

    Also known as: myomectomy

06

What researchers measure

Primary outcomes

  1. The quality of life, adverse events

    Time frame: 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

    Time frame: any time

07

Study locations

1 of 1 sites recruiting
  • The 1st Hospital of Chongqing Medical University
    Chongqing, Chongqing 400000, China
    • LD Tang, PhD · Contact · ldtang2002@yahoo.com · 13628460069
    • JINYUN CHEN, PhD · Contact · chenjinyun2006@126.com · 13668029697
    • Wen-Zhi Chen, MD · Principal investigator
    • Jin Yun Chen, PhD · Principal investigator
    • Min Zhou, PhD · Sub investigator
    • Juan Qin, PhD · Sub investigator
    • Xiaoyan Wang, PhD · Sub investigator
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01239641
Lead sponsor
Chongqing Medical University
First posted
Nov 11, 2010
Start date
Sep 2010
Primary completion
Dec 2012 (estimated)
Completion
Jul 2013 (estimated)
Last update
Nov 15, 2010

Study contacts

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
Jin-Yun Chen, PhD
principal investigator · Biomedical Engineering Department of Chongqing Medical University
Min Zhou, PhD
principal investigator · The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology
Juan Qin, PhD
principal investigator · Biomedical Engineering Department, Chongqing Medical University
Xiaoyan Wang, PhD
principal investigator · The first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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