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Study on the application of vascular network of uterine leiomyoma in HIFU ablation by three-dimensional ultrasound combined with MRI.

Study on the application of vascular network of uterine leiomyoma in HIFU ablation by three-dimensional ultrasound combined with MRI.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064679
Enrollment
Unknown
Registered
2022-10-14
Start date
2022-10-14
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Uterine leiomyoma

Interventions

Operation group:Transabdominal operation
HIFU group:HIFU ablation

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 52 Years

Inclusion criteria

Inclusion criteria: 1. Patients with premenopausal uterine fibroids diagnosed clinically and radiographically; 2. Patients with uterine fibroids who plan to undergo a HIFU ablation or surgical resection; 3. 2.5cm<maximum diameter of uterine fibroids<10cm; 4. Patients who plan to undergo hysterectomy due to other gynecological benign diseases complicated with uterine fibroids; 5. Patients are generally in good condition, and there is no language communication barriers.

Exclusion criteria

Exclusion criteria: 1. The number of uterine leiomyomas in one ablation is>=2; 2. Patients who have previously received HIFU therapy or are undergoing other treatments; 3. Patients contraindicated to MRI examination or contrast media; 4. Patients with adenomyosis, acute inflammation of the pelvic or reproductive tract, or severe systemic diseases; 5. Patients with confirmed or suspected uterine malignancy, fibroid degeneration or potential malignant transformation; 6. The volume data of target fibroids cannot be completely collected by transvaginal three-dimensional ultrasound or there is no independent acquisition window; 7. Uterine fibroids comminuted by laparoscopy.

Design outcomes

Primary

MeasureTime frame
Mean vessel density;Vascular index;Flow index;Vascularization-flow index;Vascular network of uterine leiomyoma;Signal intensity of T1WI;Non-perfusion volume ratio;

Secondary

MeasureTime frame
Signal intensity of T2WI;Uterine leiomyoma volume;Therapeutic energy;Treatment time;Sonication time;Sonication power;Therapeutic intensity;Energy Efficiency Factor, EEF;Residual volume;

Countries

China

Contacts

Public ContactHao Qiong

Affiliated Hospital of Zunyi Medical University

304345153@qq.com+86 18786301224

Outcome results

None listed

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