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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

ongoing - estimated at 3 years

Safety Issue:

No

Principal Investigator

Jim Hitchin

Investigator Role:

Study Chair

Investigator Affiliation:

SpectraScience

Authority:

United States: Institutional Review Board

Study ID:

302925

NCT ID:

NCT00358111

Start Date:

July 2006

Completion Date:

November 2010

Related Keywords:

• Dysplasia
• Cancer
• high-grade disease
• Cervical examination
• targeting biopsies
• dysplasia
• cancer

Name	Location
Women's Interventional Health	Encinitas, California  92024
U of Iowa Health Center	Iowa City, Iowa  52242