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Ultrasound ablation of uterine fibroids: A Prospective, Multicenter, Non-randomized, Parallel controlled study

Ultrasound ablation of uterine fibroids: A Prospective, Multicenter, Non-randomized, Parallel controlled study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNRC-11001188
Enrollment
Unknown
Registered
2011-02-17
Start date
2011-03-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroid

Interventions

1:High intensity focused ultrasound ablation

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. A defined diagnosis of uterine fibroids and having surgical indications for hysterectomy or myomectomy: (1) enlarged uterus, uterine size >= 10 weeks of gestation; (2) menorrhagia, secondary anemia; (3) compression symptoms. 2. No contraindication for surgery or anesthesia; 3. Informed consent obtained; 4. Other required conditions: (1) pre-menopausal women; (2) married and given birth to one children as least; (3) the number of fibroids (largest diameter >2cm) showed by abdominal ultrasound are no more than 3; (4) no attenuation (more than 10mm range) detected by abdominal US scanning.

Exclusion criteria

Exclusion criteria: 1. Patients underwent myomectomy before; 2. History of collagen connective tissue diseases or received radiotherapy; 3. Pregnant, acute inflammation of reproductive tract or other benign and malignant gynecological diseases such as, endometriosis, ovarian cancer; 4. Cervical fibroids, pedunculated subserosal fibroids and submucosal fibroids; 5. Maximum diameter of fibroid greater than 10cm or abundant blood supplement or suspected sarcoma.

Design outcomes

Primary

MeasureTime frame
efficacy;

Countries

China

Contacts

Public ContactLang Jinghe
hifuclinicaltrial@hifu.cn+86 010 65296114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026