SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

Scripps Health

Status: Completed

Conditions: Cervical Cancer

Treatments: Device: Mobile OCT M3 scope

Study type: Interventional

Funder types: Other

Identifiers

NCT02272075

Scripps-Mobile OCT 1

Details and patient eligibility

About

This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

Full 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

Enrollment: 30 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: no consent

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

active colposcope

Active Comparator group

Description:

Mobile OCT M3 scope

Treatment:

Device: Mobile OCT M3 scope

Standard of Care

No Intervention group

Description:

Standard of Care