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Efficacy and Safety of Cevira® in Patients With Cervical Histologic High-grade Squamous Intraepithelial Lesions (HSIL)

NCT04484415 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2022-08-12

No results posted yet for this study

Summary

A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL).

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2/3

Interventions

COMBINATION_PRODUCT

Cevira®

The device is a single-use, disposable, LED-based red light source. The device will automatically switch on the light 5 hours after administration, and provide continuous photoactivation of 125 J/cm2 over 4.6 hours before automatically shutting down.

COMBINATION_PRODUCT

Placebo

The placebo device is identical in appearance as the Cevira® device, but does not provide light.

Sponsors & Collaborators

  • Asieris MediTech (Hong Kong) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jinghe Lang, MD,PhD · Peking Union Medical College Hospital

  • John Zhuang, PhD · Asieris MediTech (Hong Kong) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2023-12-31
Completion
2023-12-31

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 NCT04484415 on ClinicalTrials.gov