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SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272075
Recruitment Status : Unknown
Verified October 2014 by Bruce Kahn, Scripps Health.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Bruce Kahn, Scripps Health

Brief Summary:
This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Mobile OCT M3 scope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.
Study Start Date : November 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: mobile colposcope Device: Mobile OCT M3 scope



Primary Outcome Measures :
  1. image non-inferiority [ Time Frame: 6 months ]
    imafge non-inferiority



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test -

Exclusion Criteria: no consent

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272075


Locations
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United States, California
Scripps Clinic
San Diego, California, United States, 92130
Sponsors and Collaborators
Scripps Health

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Responsible Party: Bruce Kahn, MD, Scripps Health
ClinicalTrials.gov Identifier: NCT02272075    
Other Study ID Numbers: Scripps-Mobile OCT 1
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by Bruce Kahn, Scripps Health:
screeening
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female