Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07306260
Brief 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.
Detailed Description:
This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.
Study:
NCT07306260
Study Brief:
Protocol Section:
NCT07306260