Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

SpectraScience

Status and phase: Terminated; Phase 4

Conditions: Dysplasia; Cancer

Treatments: Device: Luma Cervical Imaging System

Study type: Interventional

Funder types: Other

Identifiers

NCT00358111

302925

Details and patient eligibility

About

This is a post-approval, multi-center, single-arm study (n=950) designed to address the relationship of the LUMA device performance to patient age, patient human papillomavirus (HPV) status and colposcopist experience.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Documented abnormal pap test

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind