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Coherence Imaging of the Cervical Epithelium

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Duke University

Status

Completed

Conditions

Cervical Epithelia

Treatments

Device: mLCI Device

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02903394
Pro00070555
R01CA167421 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.

Enrollment

55 patients

Sex

Female

Ages

18 to 36 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • able to provide informed consent
  • willing to abstain from sexual intercourse for at least 24 hours before study visit

Exclusion criteria

  • pregnant
  • using an intrauterine device (IUD)
  • have a current gynecological infection or discharge
  • have had any cervical surgery
  • had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
  • currently enrolled in any research studies involving the application of vaginal formulations
  • employed or supervised by the study investigators
  • have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

55 participants in 1 patient group

mLCI imaging
Experimental group
Description:
mLCI device images cervical epithelium
Treatment:
Device: mLCI Device

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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