CO2: CO2 laser treatment is a surgical procedure that employs a high-powered carbon dioxide laser beam to precisely ablate cervical lesions. The laser is applied with a depth of 7-10mm and a width of 3-5mm beyond the lesion area in a single session. This intervention aims to address persistent low-grade cervical lesions associated with high-risk HPV infection.
Study summary
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18-65 years old with a history of sexual activity.
2. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
3. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
4. No fundamental diseases of important organs.
5. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
6. There has been no history of using other drugs related to HPV infection in the past 3 months.
Exclusion Criteria:
1. HR-HPV persistent infection.
2. A total hysterectomy has been performed.
3. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
4. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
5. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
6. Pregnant and lactating women.
7. Acute reproductive tract inflammation.
8. Diabetes patients with uncontrolled blood sugar.
9. Patients who do not receive full treatment and follow-up.
10. Those who fail to sign the informed consent form.
Primary outcome measure(s)
Regression of Cervical Lesions. — Assessed at 6 months after the last PDT session. Measure the rate of regression in cervical lesions after three PDT sessions.
Trial sites (1)
Facility
City
Region
Status
first affiliated hospital of Wenzhou medical university
Wenzhou
Zhejiang
Recruiting
More First Affiliated Hospital of Wenzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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