Study of LUMA Cervical Imaging System as Adjunct to Colposcopy

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358111

Enrollment

Registered

2006-07-28

Start date

2006-07-31

Completion date

2010-11-30

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Dysplasia

Keywords

high-grade disease, Cervical examination, targeting biopsies, dysplasia, cancer

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.

Interventions

DEVICELuma Cervical Imaging System

Colposcopy using LUMA Cervical Imaging System

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented abnormal pap test

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026