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

NCT07306260 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • HSIL, High Grade Squamous Intraepithelial Lesion
  • CIN 2
  • HPV (Human Papillomavirus)-Associated
  • Photodynamic Therapy (PDT)

Interventions

PROCEDURE

ALA-PDT

Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.

PROCEDURE

LEEP surgery

After anesthesia, cervical iodine staining was performed, followed by LEEP.

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
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306260 on ClinicalTrials.gov