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Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study


Phase 4
18 Years
45 Years
Open (Enrolling)
Female
Uterine Fibroid

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Trial Information

Safety and Efficacy of High Intensity Focused Ultrasound Ablation Compared With Myomectomy in Uterine Fibroids:A Randomized Controlled Study


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.


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‚ȧ 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The quality of life, adverse events

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

LD Tang, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

the first affiliated Chongqing University Hospital, Dept of Obstetrics and Gynecolog

Authority:

China: National Natural Science Foundation

Study ID:

H2610

NCT ID:

NCT01239641

Start Date:

September 2010

Completion Date:

July 2013

Related Keywords:

  • Uterine Fibroid
  • Uterine Fibroids
  • Myoectomy
  • High Intensity Focused Ultrasound
  • ablation
  • Leiomyoma
  • Myofibroma

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