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Clinical Trials/NCT02955667
NCT02955667
Unknown
Not Applicable

The Application of Invivo Microscopy Imaging in the Early Diagnosis of Cervical Cancer

Shanghai First Maternity and Infant Hospital0 sites600 target enrollmentDecember 2016
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ConditionsCervical CancerCervical Precancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Shanghai First Maternity and Infant Hospital
Enrollment
600
Primary Endpoint
diagnostic accuracy rate
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

This study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •cervical cytologic test result is HSIL
  • •persistent infection with high-risk HPV
  • •cervical pathological diagnosis is LSIL or HSIL

Exclusion Criteria

  • •acute infection of lower genital tract
  • •the wound in lower genital tract
  • •active bleeding in lower genital tract

Outcomes

Primary Outcomes

diagnostic accuracy rate

Time Frame: 1 day (time of the examination)

Secondary Outcomes

  • image accordance rate(1 day (time of the examination))

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