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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02955667

Enrollment

600

Registered

2016-11-04

Start date

2016-12-31

Completion date

Unknown

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Cervical Precancer

Keywords

invivo microscopy, colposcopy, cervical precancer and cancer

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.

Interventions

PROCEDUREinvivo microscopy group

patients receive invivo micro-colposcopy examination

PROCEDUREnormal group

patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. cervical cytologic test result is HSIL 2. persistent infection with high-risk HPV 3. cervical pathological diagnosis is LSIL or HSIL

Exclusion criteria

1. acute infection of lower genital tract 2. the wound in lower genital tract 3. active bleeding in lower genital tract

Design outcomes

Primary

Measure	Time frame
diagnostic accuracy rate	1 day (time of the examination)

Secondary

Measure	Time frame
image accordance rate	1 day (time of the examination)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026