A Single Arm Multi-Center Post Approval Study of LUMA as Adjunct to Colposcopy
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
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
United States: Institutional Review Board
|Women's Interventional Health||Encinitas, California 92024|
|U of Iowa Health Center||Iowa City, Iowa 52242|