HIFU vs Observation for LSIL of Cervix: A Randomized Controlled Trial

NCT07461064 | Not Yet Recruiting

• 1 other identifier: UW25-292
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

The majority of low-grade pre-invasive lesions of cervix (low-grade squamous intraepithelial lesions, LSIL).will regress spontaneously over 2 years and immediate treatment may not be necessary. According to the Hong Kong College of Obstetricians and Gynaecologists (HKCOG), if a low-grade lesion is confirmed by colposcopy and biopsy, the patient can be observed and followed up with HPV testing or co-testing at 12 months, irrespective of age. This randomized controlled study is to determine whether high-intensity focused ultrasound (HIFU) treatment of low-grade pre-invasive lesions of cervix, can cause regression of these lesions in more patients within a specific time when compared to observation as a standard management according to HKCOG Guidelines. All eligible patients will be randomized in a 1:1 ratio into 2 groups: high-intensity focused ultrasound (HIFU) or Observation group. Background information of the patients such as age, parity, body mass index, smoking status and the presence of chronic medical disease will be collected. All patients with cervical HR-HPV status will be tested. Patients randomized into HIFU group will receive HIFU treatment within 2 weeks after randomization. Those randomized into Observation group will have no intervention. All patients will attend follow-up at 6 and 12 months after randomization, during which cervical smear for cytology (with cytopathologists blinded to the treatment group) and HR-HPV testing will be performed. The rate of cytological LSIL regression and HR-HPV clearance rates at 6 and 12 months in both groups will be analyzed. Patients will be referred back to colposcopy clinic for repeat colposcopy if needed according to HKCOG Guidelines. At the 12-month follow-up visit, if referral to repeat colposcopy is not needed, patients will be referred back to their primary care physicians, Department of Health Family Health Service, Family Planning Association or other primary care centres for follow-up cervical smears.

Conditions

HPV Disease; Cervical Intraepithelial Neoplasia Grade I

Keywords

Cervical HR-HPV-related low-grade squamous intraepithelial lesion

Outcome Measures

Primary Outcomes (1)

• Efficacy of HIFU in reducing cervical HR-HPV related LSIL

  \- To determine the efficacy of HIFU in reducing cervical HR-HPV-related LSIL as evident by the reduction in the number of persistent cervical smear cytological abnormality when compared to observation as a standard management according to HKCOG Guidelines.

  12 months

Secondary Outcomes (4)

• efficacy of HIFU in clearing cervical HR-HPV

  12 months

• Efficacy of HIFU in reducing the need for repeat colposcopy

  12 months

• Safety and side effects of HIFU in the treatment of cervical LSIL

  6 months

• Patient satisfaction in using HIFU in the treatment of cervical LSIL

  1 months

Study Arms (2)

HIFU treatment group

ACTIVE COMPARATOR

high-intensity focused ultrasound (HIFU) for the management of cervical HR-HPV-related LSIL

Device: HIFU treatment

observation group

NO INTERVENTION

Observation group as a standard management according to HKCOG Guidelines

Interventions

HIFU treatment DEVICE

HIFU for the management of cervical HR-HPV-related LSIL

HIFU treatment group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Women had satisfactory colposcopy for abnormal cervical smear with positive HR-HPV test, with histologically confirmed diagnosis of cervix LSIL or CIN1.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal women aged 18 years old or above.
• Women had satisfactory colposcopy for abnormal cervical smear with positive HR-HPV test, with histologically confirmed diagnosis of cervix LSIL or CIN1.

You may not qualify if:

• Women who are pregnant or breast feeding at the time of planned HIFU treatment.
• Women without HR-HPV, or previously treated for CIN or cervical cancer.
• Women not able to attend follow up.
• Women with evidence of acute genital tract infection.
• Women with significant autoimmune diseases, immunodeficiency diseases, severe cardiac, hepatic, renal, and coagulation dysfunctions.
• Women not able to give consent.
• Participants be considered withdrawn from study or excluded from analysis
• Formally recruited into the study but withdraw from the study after randomization.
• Do not attend both follow-up appointments.

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Central Study Contacts

Vincent YT Dr. Cheung, MBBS, MRCOG, FHKAM, FRCOG

CONTACT

+85222554265; vytc@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Honorary Clinical Associate Professor

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: March 10, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03