NCT07508072

Comparison of High-Definition Electronic Magnifying Endoscopy With Image-Enhanced Technology Versus Colposcopy in the Detection of Cervical and Vaginal Lesions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

1. Primary Objective: To compare the diagnostic accuracy of high-definition electronic magnifying endoscopy combined with image-enhanced technology versus colposcopy for cervical and vaginal lesions. 2. Secondary Objectives: To evaluate and compare the sensitivity, specificity, positive predictive value, and negative predictive value of the two examination methods, and to assess the differences between the two techniques in image characteristics, such as lesion border clarity and visualization of microvascular structures.

Conditions

• Cervical Disease

Interventions

Type	Name	Description
DEVICE	high-definition electronic magnifying endoscopy combined with image-enhanced technology	High-definition magnifying endoscopy (100-150×) enables clear visualization of microvascular and mucosal structures. In recent years, magnifying endoscopy combined with image-enhanced techniques (such as NBI/BLI/LCI) has established a well-developed vascular and epithelial interpretation system for the diagnosis of early esophageal squamous cell carcinoma. The cervix, vagina, and esophagus share the same stratified squamous epithelium, and the pathological evolution of precancerous lesions and early cancer exhibits similarities. Therefore, this technical framework may theoretically be transferable to the detection of lower genital tract lesions.

Timeline

• Start date: 2026-03-28
• Primary completion: 2030-03-28
• Completion: 2030-03-28
• First posted: 2026-04-02
• Last updated: 2026-04-02