About this trial
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years old with a history of sexual activity.
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).
Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
No fundamental diseases of important organs.
Disqualifiers
HR-HPV persistent infection.
A total hysterectomy has been performed.
Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
Trial design
Parallel
Treatments tested in this trial
CO2
Procedure/SurgeryCO2 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.
Treatment groups
Trial outcomes
Primary outcomes
Regression of Cervical Lesions.
Measure the rate of regression in cervical lesions after three PDT sessions.
Secondary outcomes
Adverse Events.
Monitor and document any adverse events or complications related to CO2 laser treatment.
Sponsors and contacts
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