Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

NCT ID: NCT00358111

Last Updated: 2014-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dysplasia Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Luma Cervical Imaging System

Colposcopy using LUMA Cervical Imaging System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Documented abnormal pap test
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

SpectraScience

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Hitchin

Role: STUDY_CHAIR

SpectraScience

Locations

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Women's Interventional Health

Encinitas, California, United States

Site Status

U of Iowa Health Center

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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302925

Identifier Type: -

Identifier Source: org_study_id

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