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Research on the Clinical Efficacy and Mechanisms of High-Intensity Focused Ultrasound (HIFU) in Treating High-Grade Cervical Squamous Intraepithelial Lesion (HSIL)

Research on the Clinical Efficacy and Mechanisms of High-Intensity Focused Ultrasound (HIFU) in Treating High-Grade Cervical Squamous Intraepithelial Lesion (HSIL)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105121
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

High-Grade Cervical Squamous Intraepithelial Lesion (HSIL)

Interventions

Experimental group (FUS treatment group):Preoperative localization of the lesion area, irradiating according to optimized parameters (such as 50s/100s/300s). Immediately after surgery, perform CKC con
Control group (CKC treatment group):Conventional cold-knife conization, with postoperative pathological examination.

Sponsors

Guangzhou Women and Children's Medical Center Liuzhou Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.The cervical transformation zone is classified as Type I (fully visible) under colposcopy, with the lesion's extent and boundaries completely exposed. 2.Pathological confirmation of cervical HSIL via cervical biopsy, with negative endocervical curettage (ECC) results. 3.High-risk HPV infection confirmed by preoperative testing. 4.No prior cervical surgery or physical therapy within the last 3 months before enrollment. 5.Informed consent obtained, indicating the patient's understanding and voluntary agreement to participate in the study

Exclusion criteria

Exclusion criteria: 1.Type II-III cervical transformation zone under colposcopy (partially or completely invisible), with ill-defined lesion margins and extent. 2.Positive ECC (endocervical curettage) results, suggesting possible endocervical involvement. 3.Pathological suspicion of cervical cancer or glandular epithelial lesions. 4.History of cervical excision, cervical squamous intraepithelial lesions, or pelvic radiotherapy. 5.Active genital tract infections, including vaginitis, cervicitis, vulvitis, or pelvic inflammatory disease. 6.Severe systemic diseases, such as cardiac, hepatic, or renal dysfunction, diabetes, or immune disorders. 7.Pregnancy. 8.Coagulation disorders.

Design outcomes

Primary

MeasureTime frame
Coagulation necrosis area post-tissue ablation;

Secondary

MeasureTime frame
Apoptosis rate and survival rate of cervical cancer Caski cells (flow cytometry);Postoperative bleeding time;

Countries

China

Contacts

Public ContactTao Hua

Guangzhou Women and Children's Medical Center Liuzhou Hospital

937909873@qq.com+86 135 0772 1112

Outcome results

None listed

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