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

NCT07508072 | Not Yet Recruiting

• 1 other identifier: [2026](045)
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Primary Objective:
2. 2.Secondary Objectives:

Conditions

Cervical Disease

Outcome Measures

Primary Outcomes (7)

• diagnostic accuracy

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

• Sensitivity

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

• Specificity

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

• Positive Predictive Value (PPV)

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

• Negative Predictive Value (NPV)

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

• Area Under the Curve (AUC)

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

• Incidence of adverse events

  At the time of issuing the histopathological report following biopsy, or at the time of follow-up (6-12 months) in cases where no biopsy was performed.

Study Arms (2)

Group A

OTHER

During the examination, traditional optical colposcopy (magnification: 7.5-15×) was first used for observation and image acquisition, followed by endoscopy (preset magnification: 90-120×).

Device: high-definition electronic magnifying endoscopy combined with image-enhanced technology

Group B

OTHER

During the examination, endoscopy was performed first, followed by colposcopy.

Device: high-definition electronic magnifying endoscopy combined with image-enhanced technology

Interventions

high-definition electronic magnifying endoscopy combined with image-enhanced technology DEVICE

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.

Also known as: Traditional Colposcopy

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ① Aged 18-65 years, with indications for colposcopy (HPV16/18 positive; HPV non-16/18 positive with LCT ≥ ASCUS; HPV negative with LCT ≥ LSIL; persistent HPV infection ≥ 1 year).
• Voluntarily sign the informed consent form.

You may not qualify if:

• ① Women who are pregnant or breastfeeding.
• Acute reproductive tract infection, severe coagulation disorders. ③ History of radiotherapy for malignant tumors, study participants with severe mental illness.
• Underage women.

Sponsors & Collaborators

• West China Second University Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Diseases

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: March 28, 2026
• Primary Completion (Estimated): March 28, 2030
• Study Completion (Estimated): March 28, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03