Diagnostic Imaging Aid for Management of Cervical Lesions

Status unconfirmed · Phase 2

Conditions studied: Cervical Cancer, Cervical Intraepithelial Neoplasias, Digital Colposcopy, Precancerous Cervical Lesions

In brief

A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.

Key facts

Study ID

NCT02406365

Run by

Brookdale University Hospital Medical Center

People needed

618

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2015-04-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women who are at least 18 years old
• Women who are not pregnant as confirmed by a urine test
• Women who are not breastfeeding
• Women who understand the study procedures and can provide written informed consent

You may not qualify if…

• Women who do not meet the inclusion criteria
• Women who have had a hysterectomy

Where it is running

• Brookdale University Hospital and Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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