A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02767726

Enrollment

Registered

2016-05-10

Start date

2016-01-31

Completion date

2017-04-30

Last updated

2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women With Abnormal Pap Smears

Brief summary

Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.

Interventions

DEVICEnon-invasive multimodal imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf. * Subjects are 18 years of age or older * Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology. * Subjects are women.

Exclusion criteria

* Pregnancy. * Males (males do not have a cervix and thus cannot undergo colposcopy).

Design outcomes

Primary

Measure	Time frame
Number of suspicious lesions identified	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026