NCT02406365

Diagnostic Imaging Aid for Management of Cervical Lesions

Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 618 (estimated)
• Sponsor: Brookdale University Hospital Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cervical Cancer
• Cervical Intraepithelial Neoplasias
• Digital Colposcopy
• Precancerous Cervical Lesions

Interventions

Type	Name	Description
DEVICE	Diagnostic imaging aid for one-visit management of cervical lesions

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2015-04-02
• Last updated: 2015-04-10

Locations

1 site across 1 country: United States