MedTrace Logo

Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

NCT03502798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-02-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine:

1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells.
2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).

Conditions

  • Cervical Dysplasia

Interventions

DEVICE

scanning a/LCI

Imaging of the cervical epithelium using the scanning a/LCI device.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jacobi Medical Center

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Adam Wax, Ph.D. · professor

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2020-02-14
Completion
2020-02-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03502798 on ClinicalTrials.gov