Not Yet RecruitingNot Applicable

Multicenter Prospective Non-randomized Controlled Study of Ella Photodynamic Therapy for Cervical HSIL/CIN2

China560 participantsStarted 2026-01

Plain-language summary

This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.

Who can participate

Age range25 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Female, 25-60 years, understands study procedures and consents to participate;
✓. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2;
✓. Provides written informed consent.

Exclusion criteria

✕. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
✕. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
✕. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
✕. Undiagnosed vaginal bleeding;
✕. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents;
✕. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies;
✕. Pregnant or breastfeeding women;
✕. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser);

What they're measuring

Lesion effective rate

Timeframe: 6 months

Trial details

NCT IDNCT07306260

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Xiaoyun Wang, Doctor

15168479997 doctorwangxy@zju.edu.cn

View on ClinicalTrials.gov More HSIL, High Grade Squamous Intraepithelial Lesion trials