Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorFirst Affiliated Hospital of Wenzhou Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CO2

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: ALA-PDT GroupExperimental treatment 1 intervention
Group B: CO2 Laser GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Regression of Cervical Lesions.

Measure the rate of regression in cervical lesions after three PDT sessions.

Time frame
Assessed at 6 months after the last PDT session.

Secondary outcomes

1

Adverse Events.

Monitor and document any adverse events or complications related to CO2 laser treatment.

Time frame
Evaluated at 6 months after the CO2 laser treatment.

Other outcomes

Sponsors and contacts

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