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NCT01854983 Clinical Trial

Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

Cervical Cancer Clinical Trial

Official title:
Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01854983
Other study ID # 2012-0693
Secondary ID
Status Completed
Phase N/A
First received May 14, 2013
Last updated May 27, 2017
Start date May 2013
Est. completion date April 2014

Study information
Verified date May 2017
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

Description:

1. Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.

2. Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.

3. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.

4. After 1~2weeks follow up the subjective at opd and confirm biopsy result.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria:

1. age : 20-65 years

2. abnormal cervical papanicolaou smear , no other specific cervical disease

3. subject to colposcopic biopsy or LEEP

4. signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents

Exclusion Criteria:

1. pregnant women

2. porphyria

3. severe cervical bleeding

4. genital chlamydia, gonorrhea infection

5. other drug user with possible interaction (e.g. photosensitizer)

6. no informed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary fluorescence colposcopic result 2weeks after fluorescence colposcopy
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