HIFU vs Observation for LSIL of Cervix: A Randomized Controlled Trial (NCT07461064) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
HIFU vs Observation for LSIL of Cervix: A Randomized Controlled Trial
180 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing HIFU treatment against simple observation for low-grade cervical changes — given that LSIL often clears up on its own, how would my doctor weigh the potential benefit of actively treating it with HIFU versus just watching it closely?
2Since this trial isn't recruiting yet, what are my options right now if I have LSIL and a high-risk HPV infection — is watchful waiting or an existing standard treatment the recommended path while I wait to see if this study opens?
3HIFU is the treatment being studied here — can my doctor explain what HIFU actually does to cervical tissue, what side effects have been reported with it in other contexts, and what recovery might look like?
4Because this trial is listed as 'Phase NA,' what does that mean for how much safety and effectiveness data already exists for using HIFU specifically on cervical LSIL, and should that affect how I think about this option?
5If I were eventually eligible and enrolled, how often would I need to come in for follow-up visits, and what exactly would be checked to measure whether the HPV-related changes responded to treatment or observation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of HIFU in reducing cervical HR-HPV related LSIL