NCT00358111

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 13, 2014

Status Verified

May 1, 2014

Enrollment Period

4.3 years

First QC Date

July 27, 2006

Last Update Submit

May 12, 2014

Conditions

DysplasiaCancer

Keywords

high-grade diseaseCervical examinationtargeting biopsiesdysplasiacancer

Outcome Measures

Primary Outcomes (1)

  • Relationship between HPV and the performance of the LUMA system as an adjunct to colposcopy for detection of CIN 2,3+ will be assessed.

    ongoing - estimated at 3 years

Interventions

Luma Cervical Imaging SystemDEVICE

Colposcopy using LUMA Cervical Imaging System

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented abnormal pap test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Interventional Health

Encinitas, California, 92024, United States

Location

U of Iowa Health Center

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Jim Hitchin

    SpectraScience

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2006

First Posted

July 28, 2006

Study Start

July 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

May 13, 2014

Record last verified: 2014-05

Locations

US(2)