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To evaluate the efficacy and safety of ultrasonic gynecological therapy instrument in the treatment of cervical HPV infection: a prospective, multicenter, randomized, blank-controlled, superiority clinical trial

To evaluate the efficacy and safety of ultrasonic gynecological therapy instrument in the treatment of cervical HPV infection: a prospective, multicenter, randomized, blank-controlled, superiority clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060155
Enrollment
Unknown
Registered
2022-05-20
Start date
2022-05-13
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

cervical persistent high-risk HPV infection

Interventions

Experimental group:Ultrasonic gynecological therapy instrument
Control group:None

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 25-65 with a sexual history; 2. Patients identified by cervical HPV-DNA testing as high-risk human papillomavirus (HPV) infection with a history of at least 6 months of infection with at least one high-risk HPV subtype; 3. Patients who are willing to provide written informed consent, or whose legally authorized guardian is able to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Women with pregnancy plan during pregnancy, lactation period or within half a year; 2. Patients who have received interferon therapy in the last 10 days; 3. Patients who have received cervical physical therapy or cervical surgery within the last 3 months; 4. Patients who have received HPV vaccination in the last 6 months; 5. Patients with other diseases of the reproductive system requiring immediate treatment; 6. Patients with severe heart, brain, respiratory system diseases, liver and kidney insufficiency, coagulopathy, severe anemia or diabetes that cannot be controlled by drugs; 7. Syphilis, AIDS or other sexually transmitted diseases; 8. Cervical histopathological examination of >= high intraepithelial lesions (HSIL), including squamous or glandular epithelial origin; 9. Participated in other clinical trials within 30 days; 10. The investigator did not consider it appropriate to participate in this clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Overall effective efficiency of cervical high-risk HPV clearance;

Secondary

MeasureTime frame
Vaginal bleeding;Incidence rate of device failure;Incidence rate of adverse event and serious adverse event;

Countries

China

Contacts

Public ContactYang Bing
yangbing2188@163.com+86 851 28609165

Outcome results

None listed

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