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Cervical Cancer Screening in Madagascar Using Smartphone Photos and Mobile Telemedicine

NCT02693379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1041

Last updated 2016-02-26

No results posted yet for this study

Summary

The purpose of this study is to determine whether smartphone photos may assist health-care worker (on-site) and to evaluate the diagnostic reliability and accuracy of cervical examination with smartphone photos of VIA (D-VIA), on-site and off-site, compared with conventional VIA, for human papillomavirus (HPV) positive women.

Conditions

  • Cervical Precancer

Interventions

DEVICE

D-VIA

D-VIA images were captured during the cervical examination with a smartphone. Biopsies and cytological samples were taken on all patients and analyzed for gold standard results. Images were shown to off site experts. D-VIA and VIA diagnoses were then compared. Women who were diagnosed on-site as pathological underwent appropriate treatment at the same consultation. Women who were diagnosed as pathological later by histopathological analyses were asked to return to the clinic for treatment.

Sponsors & Collaborators

  • Prof. Patrick Petignat

    lead OTHER

Principal Investigators

  • Patrick Petignat, Professor · University Hospital, Geneva

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-09-30
Completion
2015-11-30

Countries

  • Madagascar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02693379 on ClinicalTrials.gov