Multicenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection
NCT07306247 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225
Last updated 2025-12-29
Summary
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Conditions
- HPV-16/18
- Photodynamic Therapy (PDT)
- LSIL, Low Grade Squamous Intraepithelial Lesion
Interventions
- PROCEDURE
-
ALA-PDT
Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
Sponsors & Collaborators
-
Women's Hospital School Of Medicine Zhejiang University
collaborator OTHER -
First People's Hospital of Hangzhou
collaborator OTHER -
First Affiliated Hospital of Ningbo University
collaborator NETWORK -
Shaoxing People's Hospital
collaborator OTHER -
Linping First People's Hospital
collaborator UNKNOWN -
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2027-01-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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