Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

NCT00358111 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-05-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Luma Cervical Imaging System

Colposcopy using LUMA Cervical Imaging System

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER
  • SpectraScience

    lead OTHER

Principal Investigators

  • Jim Hitchin · SpectraScience

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00358111 on ClinicalTrials.gov