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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • ALA-PDT
  • LEEP surgery

Treatment groups

560 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Collaborator

First People's Hospital of Hangzhou

Collaborator

First Affiliated Hospital of Ningbo University

Collaborator

Shaoxing People's Hospital

Collaborator

Linping First People's Hospital

Collaborator