Not provided
Not provided
Not provided
Not provided
Not provided
PMA withdrawn
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Iowa | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luma Cervical Imaging System | Device | Colposcopy using LUMA Cervical Imaging System |
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jim Hitchin | SpectraScience | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Interventional Health | Encinitas | California | 92024 | United States | ||
| U of Iowa Health Center |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Iowa City |
| Iowa |
| 52242 |
| United States |