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NCT Number: NCT07508072

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

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.

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Key information

Conditions

Cervical Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Traditional Colposcopy

Primary outcomes

  1. diagnostic accuracy

    Time frame: 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.

  2. Sensitivity

    Time frame: 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.

  3. Specificity

    Time frame: 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.

  4. Positive Predictive Value (PPV)

    Time frame: 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.

  5. Negative Predictive Value (NPV)

    Time frame: 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.

  6. Area Under the Curve (AUC)

    Time frame: 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.

  7. Incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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