Back to resultsSmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile OCT M3 scope
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring screeening
Eligibility Criteria
Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test -
Exclusion Criteria: no consent
-
Sites / Locations
- Scripps Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
active colposcope
Standard of Care
Arm Description
Mobile OCT M3 scope
Standard of Care
Outcomes
Primary Outcome Measures
image non-inferiority
imafge non-inferiority
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02272075
Brief Title
SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
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 Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scripps Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
screeening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active colposcope
Arm Type
Active Comparator
Arm Description
Mobile OCT M3 scope
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care
Intervention Type
Device
Intervention Name(s)
Mobile OCT M3 scope
Primary Outcome Measure Information:
Title
image non-inferiority
Description
imafge non-inferiority
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test -
Exclusion Criteria: no consent
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Kahn, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
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