Trial Outcomes & Findings for A See and Treat Paradigm for Cervical Pre-cancer (NCT NCT02477124)
NCT ID: NCT02477124
Last Updated: 2023-05-18
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
514 participants
Primary outcome timeframe
Up to approximately 10 minutes
Results posted on
2023-05-18
Participant Flow
Cervical images obtained across 6 countries to build a database of 1000+ images to develop AI software for cervical cancer screening.
Participant milestones
| Measure |
Transvaginal Digital Colposcope (TVCD)
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue.
|
|---|---|
|
Overall Study
STARTED
|
514
|
|
Overall Study
COMPLETED
|
514
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A See and Treat Paradigm for Cervical Pre-cancer
Baseline characteristics by cohort
| Measure |
Transvaginal Digital Colposcope (TVCD)
n=514 Participants
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
514 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
514 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
200 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
314 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
125 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
189 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
200 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Tanzania
|
100 participants
n=99 Participants
|
|
Region of Enrollment
Zambia
|
89 participants
n=99 Participants
|
|
Region of Enrollment
Peru
|
200 participants
n=99 Participants
|
|
Region of Enrollment
India
|
125 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 10 minutesPopulation: We have SOC Images from these 514 participants AND the images obtained with our research device. Therefore we have 2 photos for each step in the colposcopy procedure process
Outcome measures
| Measure |
Transvaginal Digital Colposcope (TVCD)
n=514 Participants
Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue.
|
|---|---|
|
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
|
514 Participants
|
Adverse Events
Transvaginal Digital Colposcope (TVCD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place