Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

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ClinicalTrials.gov Identifier: NCT00358111

Recruitment Status : Terminated (PMA withdrawn)

First Posted : July 28, 2006

Last Update Posted : May 13, 2014

Sponsor:

Collaborator:

University of Iowa

Information provided by (Responsible Party):

SpectraScience

Tracking Information

First Submitted Date ^ICMJE

July 27, 2006

First Posted Date ^ICMJE

July 28, 2006

Last Update Posted Date

May 13, 2014

Study Start Date ^ICMJE

July 2006

Actual Primary Completion Date

November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed. [ Time Frame: ongoing - estimated at 3 years ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

Official Title ^ICMJE

A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Dysplasia
Cancer

Intervention ^ICMJE

Device: Luma Cervical Imaging System

Colposcopy using LUMA Cervical Imaging System

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

November 2010

Actual Primary Completion Date

November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Documented abnormal pap test

Sex/Gender ^ICMJE

Sexes Eligible for Study:

Female

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00358111

Other Study ID Numbers ^ICMJE

302925

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

SpectraScience

Study Sponsor ^ICMJE

SpectraScience

Collaborators ^ICMJE

University of Iowa

Investigators ^ICMJE

Study Chair:

Jim Hitchin

SpectraScience

PRS Account

SpectraScience

Verification Date

May 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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