HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2

Inclusion Criteria:

• Voluntarily participate in this clinical study, fully understand the study content, procedures, and potential adverse reactions, and be able to sign the written informed consent form.

Able to complete the study in accordance with the study protocol.

Female aged ≥18 years and ≤50 years.

Newly diagnosed High-Grade Squamous Intraepithelial Lesion (HSIL), cervical intraepithelial neoplasia grade 2 (CIN2) within 3 months, specifically: CIN2 confirmed by tissue biopsy within 3 months prior to the first treatment.

Note: Histopathological diagnosis will be assessed by the pathology department of the participating hospital for enrollment.

Adequate colposcopy, including:

Complete visibility of the cervical transformation zone, including the squamocolumnar junction;

Complete visibility of lesion margins;

No lesion extension into the cervical canal.

Cervical size deemed suitable for placement of the HAL-PDT device as assessed by the investigator according to the HAL-PDT package insert.

Meets the following conditions: negative pregnancy test; no plan for pregnancy during the study period; no sexual activity or use of effective and reliable contraception from the end of the last menstrual period to the start of the study, and agreement to use condoms for barrier contraception during the study period.

Exclusion Criteria:

• Subjects who meet any of the following criteria will be excluded from this study:

Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.

Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.

Prior treatment (surgical or physical therapy) for the condition, or receipt of physical or surgical therapy within 3 months after the current histopathological diagnosis of CIN2.

The date of the first HAL-PDT treatment falls within 7 half-lives of the last antiviral medication.

History of toxic shock syndrome.

Severe pelvic inflammatory disease, severe cervicitis, or other severe gynecological infectious diseases found on colposcopic or clinical examination.

Investigator judges that vaginal bleeding during treatment may affect treatment outcomes.

Receipt of any inactivated vaccine within 2 weeks prior to the first treatment, or any live vaccine within 4 weeks prior to the first treatment.

Previous severe cardiovascular, cerebrovascular, neurological, psychiatric, endocrine, or hematopoietic disease that has not been cured; known severely compromised immune function, or need for long-term use of corticosteroids or immunosuppressants; history of malignancy within 5 years.

History of clinically significant immunosuppression or confirmed autoimmune disease; or primary immunodeficiency.

Known or newly identified active sexually transmitted diseases (STDs), including but not limited to HIV, syphilis, genital herpes, unless adequately treated and tested negative before study treatment.

Presence of a cardiac pacemaker.

Suspected or known porphyria, or known allergy to hexaminolevulinate, its chemically similar compounds, or photosensitizers.

Allergy to silicone.

Pregnant or breastfeeding women.

Delivery or miscarriage within 6 weeks prior to enrollment.

Participation in any other clinical trial within 30 days prior to HAL-PDT treatment.

Poor compliance or judged by the investigator to be unsuitable for participation in this clinical study.