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Not yet recruiting NCT07508072

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

No phase Interventional Cervical Disease

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: high-definition electronic magnifying endoscopy combined with image-enhanced technology.
Who it may be relevant to
Registry conditions: Cervical Disease. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 e

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07508072 · [2026](045)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗