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Clinical study of high intensity focused ultrasound (HIFU) combined with hot bulb endometrial ablation (TBEA) in the treatment of adenomyosis related abnormal uterine bleeding

Clinical study of high intensity focused ultrasound (HIFU) combined with hot bulb endometrial ablation (TBEA) in the treatment of adenomyosis related abnormal uterine bleeding

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043453
Enrollment
Unknown
Registered
2021-02-18
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Adenomyosis

Interventions

experimental group:HIFU ablation combined with TBEA
control group:HIFU ablation

Sponsors

Mianyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Patients with diffuse adenomyosis and abnormal uterine bleeding; 2. Patients who are unable to tolerate or fail to receive drug treatment (including LNG-IUS treatment failure); 3. Subjects who required to keep uterus and had no fertility requirements; 4. Subjects with unilateral myometrial thickening >= 30mm indicated by transvaginal ultrasound; 5. For the subjects with good acoustic channel located by HIFU before operation, the focus moving area can cover the scope of the lesions to be treated.

Exclusion criteria

Exclusion criteria: 1. Patients with fertility requirements. 2. Patients with severe anteflexion and retroflexion of uterus, genital tract deformity, or adhesion of cervix and uterine cavity, intrauterine mediastinum. 3. Patients who have undergone endometrial resection or ablation, or who have undergone HIFU ablation. 4. Patients with non benign uterine diseases. 5. Subjects with pregnancy or suspected pregnancy. 6. Patients with severe internal and external diseases can not tolerate HIFU or TBEA. 7. Patients who received other treatments (including GnRHa, gestrinone, uterine artery embolization, etc.) in the past three months. 8. Subjects who can not cooperate with HIFU treatment and complete the follow-up after operation.

Design outcomes

Primary

MeasureTime frame
PBAC;

Secondary

MeasureTime frame
dysmenorrhea;

Countries

China

Contacts

Public ContactZhang Yong

Department of Obstetrics & Gynecology, Mianyang Central Hospital

13808110138@163.com+86 13808110138

Outcome results

None listed

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