Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458062
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-10
Brief Title:
Pocket Colposcopy Using CARE Algorithm
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Pocket colposcope has 510k FDA clearance and has been successfully used in 2500 unique patients globally in Duke and non-Duke protocols to date 1054 women who are HPV and planned to undergo treatment at 4-6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study After providing informed consent participants will be proceed with colposcopy using the POCKET colposcope
Detailed Description:
Women undergo Pocket-Assisted VIA PA-VIA and green light imaging using the Pocket Colposcope Women will have biopsies taken of any suspicious lesions or two biopsies taken in random locations if no lesions are visible The locations of the biopsies will be based on provider impression After their study-exams and biopsies are taken women who are eligible for ablative treatment will be immediately treated in the clinic Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure Once we have obtained enough images to develop the CARE algorithm it will also be used to assist the provider in diagnosis
This record reflects Aim 3 of the grant
This record reflects Aim 3 of the grant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01CA269192 | NIH | None | httpsreporternihgovquickSearch1U01CA269192 |